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Original Investigation |

Glaucoma-Related Adverse Events in the First 5 Years After Unilateral Cataract Removal in the Infant Aphakia Treatment Study FREE

Sharon F. Freedman, MD1; Michael J. Lynn, MS2; Allen D. Beck, MD3; Erick D. Bothun, MD4,5,6; Faruk H. Örge, MD7; Scott R. Lambert, MD3 ; for the Infant Aphakia Treatment Study Group
[+] Author Affiliations
1Duke Eye Center, Duke University Medical Center, Durham, North Carolina
2Department of Biostatistics and Bioinformatics, Rollins School of Public Health of Emory University, Atlanta, Georgia
3Department of Ophthalmology, Emory University School of Medicine, Atlanta, Georgia
4Department of Ophthalmology, University of Minnesota, Minneapolis
5Department of Neurovisual Sciences, University of Minnesota, Minneapolis
6Department of Pediatrics, University of Minnesota, Minneapolis
7Department of Ophthalmology, Case Medical Center University Hospitals, Cleveland, Ohio
JAMA Ophthalmol. 2015;133(8):907-914. doi:10.1001/jamaophthalmol.2015.1329.
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Published online

Importance  Glaucoma-related adverse events constitute major sight-threatening complications of cataract removal in infancy, yet their relationship to aphakia vs primary intraocular lens (IOL) implantation remains unsettled.

Objective  To identify and characterize cases of glaucoma and glaucoma-related adverse events (glaucoma + glaucoma suspect) among children in the Infant Aphakia Treatment Study by the age of 5 years.

Design, Setting, and Participants  A multicenter randomized clinical trial of 114 infants with unilateral congenital cataract in referral centers who were between ages 1 and 6 months at surgery. Mean follow-up was 4.8 years. This secondary analysis was conducted from December 23, 2004, to November 13, 2013.

Interventions  Participants were randomized at cataract surgery to either primary IOL or no IOL implantation (contact lens). Standardized definitions of glaucoma and glaucoma suspect were created for the Infant Aphakia Treatment Study and applied for surveillance and diagnosis.

Main Outcomes and Measures  Development of glaucoma and glaucoma + glaucoma suspect in operated on eyes for children up to age 5 years, plus intraocular pressure, visual acuity, and axial length at age 5 years.

Results  Product limit estimates of the risk for glaucoma and glaucoma + glaucoma suspect at 4.8 years after surgery were 17% (95% CI, 11%-25%) and 31% (95% CI, 24%-41%), respectively. The contact lens and IOL groups were not significantly different for either outcome: glaucoma (hazard ratio [HR], 0.8; 95% CI, 0.3-2.0; P = .62) and glaucoma + glaucoma suspect (HR, 1.3; 95% CI, 0.6-2.5; P = .58). Younger (vs older) age at surgery conferred an increased risk for glaucoma (26% vs 9%, respectively) at 4.8 years after surgery (HR, 3.2; 95% CI, 1.2-8.3), and smaller (vs larger) corneal diameter showed an increased risk for glaucoma + glaucoma suspect (HR, 2.5; 95% CI, 1.3-5.0). Age and corneal diameter were significantly positively correlated. Glaucoma was predominantly open angle (19 of 20 cases, 95%), most eyes received medication (19 of 20, 95%), and 8 of 20 eyes (40%) underwent surgery.

Conclusions and Relevance  These results suggest that glaucoma-related adverse events are common and increase between ages 1 and 5 years in infants after unilateral cataract removal at 1 to 6 months of age; primary IOL placement does not mitigate their risk but surgery at a younger age increases the risk. Longer follow-up of these children may further characterize risk factors, long-term outcomes, potential differences between eyes having primary IOL vs aphakia, and optimal timing of unilateral congenital cataract removal.

Trial Registration  clinicaltrials.gov Identifier: NCT00212134

Figures in this Article

Glaucoma is a well-documented and serious complication after childhood cataract removal, with reported frequency and risk factors for glaucoma and glaucoma suspect varying by study population, definition, and follow-up time in a variety of retrospective studies.112 The Infant Aphakia Treatment Study (IATS)—a multicenter randomized clinical trial sponsored by the National Eye Institute—compares outcomes of surgery for unilateral cataract with primary intraocular lens (IOL) implantation to surgery without IOL implantation in infants between 1 and 6 months of age.1317

Definitive knowledge of the relationship between primary IOL placement at the time of congenital cataract removal and glaucoma risk remains to be ascertained. While some studies have reported decreased glaucoma frequency among eyes with primary IOL implantation after cataract removal in the first year of life,1820 others have noted a similar frequency1,1012,21 but all lacked randomization regarding primary IOL placement.

In this article, we report 5-year results of the development of glaucoma-related adverse events in IATS participants.

Box Section Ref ID

At a Glance
  • To identify and characterize cases of glaucoma + glaucoma suspect among children in the Infant Aphakia Treatment Study by age 5 years.

  • The risk for glaucoma at 4.8 years after cataract removal was 17% (95% CI, 11%-25%).

  • The risk for glaucoma + glaucoma suspect at 4.8 years after cataract removal was 31% (95% CI, 24%-41%).

  • Younger age at surgery conferred an increased risk for glaucoma (hazard ratio, 3.2; 95% CI, 1.2-8.3).

  • Smaller corneal diameter increased the risk for glaucoma + glaucoma suspect (hazard ratio, 2.5; 95% CI, 1.3–5.0).

  • Glaucoma was predominantly open angle (19 of 20 cases, 95%), most eyes received medication (95%), and 8 of 20 (40%) underwent glaucoma surgery.

The IATS design, surgical technique, follow-up schedule, patching and optical correction regimens, evaluation methods, and patient characteristics at baseline have been previously reported in detail (eAppendix in the Supplement).14 The definitions for glaucoma, glaucoma suspect, and glaucoma-related adverse events (glaucoma + glaucoma suspect) were established and rigorously applied, as previously reported (Table 1).13

Table Graphic Jump LocationTable 1.  Definitions of Glaucoma, Glaucoma Suspect, and Glaucoma-Related Adverse Event

The IATS was not originally designed to capture detailed information about the diagnosis, treatment, and course of glaucoma. However, medical record information was obtained from sites to enable the medical monitor to (1) verify application of standard definitions for glaucoma and glaucoma suspect and (2) confirm that appropriate care was provided to study participants. Available information on intraocular pressure (IOP), optic nerve head (cup-disc ratios recorded by the clinician), medications, and glaucoma surgery was gathered from these records. Statistical considerations are provided in the eAppendix in the Supplement.

For this study conducted from December 23, 2004, to November 13, 2013, institutional review board approval was obtained from each of the participating centers and written informed consent was obtained from the parents/guardians of each enrolled child.

Development of Glaucoma

The IATS randomized 114 infants (57 each to the contact lens [CL] and IOL groups); 113 completed clinical examination at age 5 years (mean, 5.0 years; range, 4.7-5.4), with mean postsurgical follow-up of 4.8 years (range, 4.4-5.3 years), and 1 participant (IOL group) was lost to follow-up at 18 months.

By the 5-year follow-up, 20 eyes (18%) had developed glaucoma, and 16 additional eyes were glaucoma suspects (glaucoma + glaucoma suspect, 36 eyes total [32%]). The CL group had 9 eyes (16%) with glaucoma and 11 (19%) were glaucoma suspects (glaucoma + glaucoma suspect, 20 eyes total [35%]). The IOL group had 11 eyes (19%) with glaucoma and 5 (9%) were glaucoma suspects (glaucoma + glaucoma suspect, 16 eyes total [28%]).

In Kaplan-Meier analysis, for all study eyes combined, the risk for glaucoma after cataract removal increased from 9% (95% CI, 5%-16%) at 1 year to 17% (95% CI, 11%-25%) at 4.8 years (Figure 1A; eTable 1 in the Supplement); the risk for glaucoma + glaucoma suspect diagnosis after cataract removal increased from 12% (95% CI, 7%-20%) at 1 year to 31% (95% CI, 24%-41%) at 4.8 years (Figure 1B; eTable 1 in the Supplement).

Place holder to copy figure label and caption
Figure 1.
Kaplan-Meier Curves Showing the Cumulative Probability of Glaucoma and Glaucoma + Glaucoma Suspect Against Time After Cataract Surgery

One additional child in the contact lens group had glaucoma diagnosed at 4.9 years, which increased the cumulative probability to 43% (95% CI, 12%-91%). The dashed lines represent 95% CIs.

Graphic Jump Location

Kaplan-Meier curves for developing glaucoma after cataract removal were not significantly different between the CL and IOL treatment groups (hazard ratio [HR], 0.8; 95% CI, 0.3-2.0; P = .62; Figure 2A; eTable 1 in the Supplement), with the risk rising in the CL and IOL groups from 5% (95% CI, 2%-15%) and 12% (95% CI, 6%-24%), respectively, at 1 year to 14% (95% CI, 7%-26%) and 19% (95% CI, 11%-32%), respectively, at 4.8 years. Kaplan-Meier curves for developing glaucoma + glaucoma suspect diagnosis after cataract removal were also not significantly different between the treatment groups (HR, 1.3; 95% CI, 0.6-2.5; P = .58; Figure 2B; eTable 1 in the Supplement), with the risk rising in the CL and IOL groups from 9% (95% CI, 4%-20%) and 16% (95% CI, 9%-28%), respectively, at 1 year to 34% (95% CI, 23%-48%) and 28% (95% CI, 18%-42%), respectively, at 4.8 years.

Place holder to copy figure label and caption
Figure 2.
Kaplan-Meier Curves Showing the Cumulative Probability of Glaucoma and Glaucoma + Glaucoma Suspect Against Time After Cataract Surgery According to the Treatment Assignment

CL indicates contact lens; IOL, intraocular lens.

Graphic Jump Location
Cases of Glaucoma and Glaucoma Suspect Since the 1-Year Follow-up

Glaucoma was diagnosed in 10 eyes between the 1-year postoperative visit and at age 5 years (6 CL and 4 IOL). Six eyes that were glaucoma suspects at 1 year converted to glaucoma by the visit at age 5 years. Thirteen eyes became glaucoma suspects during the same time interval (10 CL and 3 IOL).

Influence of Baseline Characteristics of Enrolled Children/Study Eyes

Bivariate analyses evaluated selected baseline characteristics relative to the development of glaucoma and glaucoma + glaucoma suspect (Table 2). Children in the younger age strata at cataract surgery were at higher risk for developing glaucoma than older children by 4.8 years postoperatively (26% vs 9%, respectively; P = .01) and glaucoma + glaucoma suspect (45% vs 21%, respectively; P = .006). Eyes with smaller corneal diameter (≤10 mm) at cataract removal were also at higher risk for glaucoma + glaucoma suspect (but not of glaucoma) than those having larger corneas by 4.8 years postoperatively (50% vs 20%, respectively; P = .001). Neither persistent fetal vasculature (PFV) diagnosis nor IOP at surgery was associated with risk for either glaucoma or glaucoma + glaucoma suspect diagnoses by 4.8 years.

Table Graphic Jump LocationTable 2.  Baseline Characteristics of Children in the Infant Aphakia Treatment Study vs Development of Glaucoma and Glaucoma + Glaucoma Suspect

Multivariate analysis for glaucoma considered factors including age strata, CL vs IOL group, PFV, corneal diameter, and IOP at surgery: age strata was associated with glaucoma (HR [younger vs older], 3.2; 95% CI, 1.2-8.3; P = .02); no association was identified with any of the other factors after accounting for age. In the multivariate analysis for glaucoma + glaucoma suspect diagnoses, corneal diameter was associated with glaucoma + glaucoma suspect (HR [≤10 mm vs >10 mm], 2.9; 95% CI, 1.5-5.7; P = .002); no association was identified with any of the other factors after accounting for corneal diameter. Not surprisingly, there was a moderately high positive correlation between age and corneal diameter (r = 0.65, P < .001); hence, when one of these variables was in the model, an association with outcome was not identified for the other variable. Similar results were found for the bivariate and multivariate analyses with age at surgery, IOP, and corneal diameter in continuous form and are reported in eTable 2 in the Supplement.

Glaucoma Characteristics, Treatment, and Outcomes

Although detailed gonioscopic information was not collected as part of the IATS, 19 of 20 eyes with glaucoma were assumed to be open angle, while 1 eye had iris bombe and angle closure. All 16 eyes with glaucoma suspect diagnosis were assumed to have open angles.

Diagnostic Criteria for Diagnosis

Among the 20 eyes diagnosed as having glaucoma, 13 (65%) showed IOP greater than 21 mm Hg with anatomic changes: corneal enlargement (3 eyes, with 2 having myopic shift), increased optic nerve cupping (8 eyes, with 1 having myopic shift), and myopic shift only (2 eyes). Seven eyes (35%) were diagnosed either by requiring glaucoma surgery (n = 4), or by 2 or more other diagnostic criteria (n = 3). Among the 16 eyes diagnosed as glaucoma suspect, 10 eyes (63%) met criteria by elevated IOP (>21 mm Hg), while 6 eyes (38%) were treated with glaucoma medications, without strictly meeting IOP diagnostic criteria.

The mean (SD) maximum IOP recorded was elevated in eyes with glaucoma and with glaucoma suspect diagnoses (32.1 [9.0] vs 28.9 [4.9] mm Hg, respectively) compared with eyes having neither diagnosis (18.8 [2.9] mm Hg; P < .001 for both comparisons). The mean (SD) maximum IOP recorded was similar for eyes with glaucoma in the CL (n = 9) vs IOL groups (n = 11): 34.7 (6.6) vs 30.0 (10.5) mm Hg, respectively (P = .26). The mean (SD) maximum recorded IOP in eyes diagnosed as glaucoma suspects was similar in the CL and IOL groups (27.9 [3.0] vs 30.9 [7.8] mm Hg, respectively; P = .44).

The optic nerve head cup-disc (CD) ratio was recorded subjectively by investigators without imaging. While the maximum recorded CD ratio varied widely, the mean (SD) CD ratio was larger in eyes diagnosed as having glaucoma (0.45 [0.22]; n = 19) vs glaucoma suspect (0.19 [0.10]; n = 15) (P < .001), with no significant difference between the CL and IOL groups within each respective diagnostic group.

Glaucoma Treatment

Glaucoma medications were prescribed for 19 of 20 eyes (95%) with glaucoma and 12 of 16 eyes (75%) diagnosed as glaucoma suspects; 8 of 20 eyes (40%) with glaucoma had glaucoma surgery by the visit at age 5 years (eTable 3 in the Supplement). The eye with angle closure (CL group) had limited anterior vitrectomy, pupillary membrane removal, and surgical peripheral iridectomy; despite glaucoma control postoperatively, the eye subsequently experienced retinal detachment and, ultimately, phthisis. Glaucoma surgical procedures were performed in 7 of 19 eyes (37%) with open-angle glaucoma: 5 of 11 (45.5%) in the IOL group and 2 of 9 (22.2%) in the CL group (P = .37). Surgical procedures included trabeculotomy, Baerveldt glaucoma drainage implant, and endoscopic diode laser (eTable 3 in the Supplement).

Of the 10 additional glaucoma cases diagnosed between the 1-year postoperative visit and the follow-up at age 5, only 1 additional eye (10%) has had glaucoma surgery. Of the 7 eyes requiring glaucoma surgery for open-angle glaucoma, 5 occurred within the first year following cataract removal. At the 5-year follow-up, these 7 eyes had mean (SD) IOP of 18.3 (3.9) mm Hg, with 4 taking glaucoma medication.

Glaucoma and Ocular Parameters at the Follow-up at Age 5 Years

The IOP at approximately age 5 years was available for 112 patients. Mean (SD) IOP was similar in eyes diagnosed as either having glaucoma (n = 19) or glaucoma suspect (n = 16; 20.2 [6.5] mm Hg vs 21.6 [4.5] mm Hg, respectively) and different from the eyes with neither diagnosis (n = 77; 16.8 [3.9] mm Hg) (P < .01 for both comparisons). The mean (SD) axial length at the age 5 follow-up visit was significantly longer in eyes with glaucoma (n = 13; 23.3 [2.0] mm) than those diagnosed as neither having glaucoma nor glaucoma suspect (n = 72; 21.4 [1.6] mm; P = .001); eyes diagnosed as glaucoma suspects (n = 12) had mean (SD) axial length of 22.0 (2.2) mm, not different from the means of either of the other 2 groups.

Glaucoma and Visual Acuity

Median visual acuity at age 4.5 years was 20/283 in eyes with glaucoma (n = 20), 20/141 in eyes with glaucoma suspect (n = 16), and 20/100 in eyes with neither diagnosis (n = 76); these 3 groups were not statistically different (P = .13). Results according to visual acuity categories are provided in eTable 4 in the Supplement.

Glaucoma developed in the operated on eyes of 20 of 113 infants (18%) with unilateral cataract enrolled in the IATS by age 5 years; an additional 16 eyes were glaucoma suspects, for a total of 36 operated on eyes (32%) with glaucoma + glaucoma suspect diagnosis. The risk for developing glaucoma increased in both the CL and IOL groups between 1 and 4.8 years after cataract surgery (from 5% to 14% and from 12% to 19%, respectively), as did the risk for glaucoma + glaucoma suspect diagnosis (from 9% to 34% and from 16% to 28%, respectively). Of the 13 additional cases of glaucoma suspect diagnosed between the 1 year postoperative and age 5 visits, 10 were in the CL group; these differences by treatment group were not statistically significant. Additionally, we noted a relative lull in the diagnosis of glaucoma + glaucoma suspect diagnoses between 1 and 3 years postcataract removal. However, the IATS protocol only required IOP assessment at examination at 1 year old under anesthesia and the visits at ages 4, 4.5, or 5, so surveillance bias was possible.

While most retrospective studies of glaucoma following cataract removal in infancy have lacked uniform diagnostic criteria for that complication, the 17% chance of glaucoma by 4.8 years after surgery in the IATS is consistent with other studies,5,6 including a meta-analysis reporting glaucoma in 80 of 470 eyes (17%) after cataract surgery at a median age of 3 months, with median onset 4.3 years postsurgery.19 Despite varying definitions of glaucoma used in published studies, it is clear that a significant percentage of children undergoing congenital cataract surgery develop glaucoma (or at least elevated IOP), usually with open angles, and the onset of glaucoma frequently occurs years after cataract surgery.1,2,6,7,22

Numerous mechanisms for the development of glaucoma after cataract removal in infancy have been postulated.2,6,7,911,18,2225 Because the IATS was not designed to investigate the mechanism of glaucoma-related adverse events, we could not differentiate among various proposed mechanisms of open-angle glaucoma but confirmed that modern surgical techniques do not eliminate this complication.2,14

There is controversy surrounding the possible protective effect of primary IOL implantation (vs aphakia) against glaucoma after cataract removal in infancy, with published reports both supporting18,19 and failing to demonstrate this protective effect.10,11 Trivedi et al10 noted that all glaucoma cases occurred in eyes having cataract surgery in the first 4.5 months of life, with similar rates in aphakic vs pseudophakic eyes (19% vs 24%, respectively). Mataftsi and colleagues19 noted a protective effect of primary IOL vs aphakia in their large meta-analysis (HR, 0.1; P = .02); however, eyes were not randomized to primary IOL vs aphakia, and a consistent definition of glaucoma was not applied. The IATS—by virtue of its randomization and prospective design—lacks the potential bias of prior nonrandomized studies.14 Neither glaucoma nor glaucoma + glaucoma suspect diagnoses were statistically different between pseudophakic and aphakic eyes at the 1-year follow-up.13 We report an increase in both glaucoma and glaucoma suspect cases by the visit at age 5 in the IATS but no statistically significant difference in either complication by treatment group (IOL vs CL). Continued follow-up will be critical to more definitively answer the question of the possible protective effect of primary IOL placement, especially because reported onset of glaucoma occurs at a mean 4 to 5 years after cataract removal.6,7,19,23

Standard definitions of glaucoma and glaucoma suspect were developed and uniformly applied for surveillance and diagnosis of eyes within the IATS, with the former requiring not only elevated IOP, but also associated structural changes in the infant eye or need for glaucoma surgery.13 Many prior studies have defined glaucoma solely by elevated IOP or by the physician’s decision to start treatment,19 without including secondary structural change among the diagnostic criteria.2,6,7,23 The importance of a uniformly accepted definition of glaucoma as well as glaucoma suspect will facilitate future research and comparison among different published works.26 The definitions of glaucoma and glaucoma suspect developed for the IATS13 were adopted by the World Glaucoma Association consensus group.26

Among various risk factors previously evaluated for the development of glaucoma following cataract surgery in children, young age at surgery has been frequently identified.10,2729 Younger patient age at surgery (28-48 vs 49-210 days old) was also noted as a risk factor for the development of a glaucoma-related adverse event in the IATS at 1 year,13 despite deferring cataract surgery until at least age 4 weeks based on previous studies suggesting increased glaucoma risk if surgery is performed in the first 4 weeks of life.27,30 At the visit at age 5 years, children in the younger age strata (28-48 vs >48 days old) at cataract surgery were again noted to be at higher risk for developing glaucoma and glaucoma-related adverse events.

Multivariate analysis (considering age at surgery, corneal diameter, presence of PFV, and IOP at surgery) showed that only younger age at surgery increased the risk for developing glaucoma (by 3.2 times); only smaller corneal diameter at surgery (≤10 mm vs >10 mm) increased the risk for developing glaucoma + glaucoma suspect (by 2.9 times). This was not unexpected because young age at surgery and smaller corneal diameter were highly correlated. Because eyes with severe PFV were excluded from the IATS, it is not surprising that this feature was not noted to confer additional risk for glaucoma + glaucoma suspect diagnosis by 5 years. Evaluation of the relationship between visual acuity at 4.5 years of age and age at surgery in the IATS (28-48 vs 49-210 days at surgery) revealed median visual acuity was significantly better for eyes operated on younger vs older (0.50 vs 1.10 logMAR [Snellen equivalent, 20/63 vs 20/250]; P = .046).31 Therefore, the desire to achieve maximum visual acuity must be counterbalanced against an increased risk for glaucoma or glaucoma suspect diagnosis in an infant with a unilateral congenital cataract.

As expected, based on the definitions of glaucoma and glaucoma suspect in the IATS, eyes with these diagnoses had higher maximum recorded IOP than those without them by the visit at age 5 years. The optic nerves showed a larger CD ratio in eyes with glaucoma than those with glaucoma suspect or without either diagnosis; the axial length was longer in eyes with glaucoma than in eyes with glaucoma suspect or without a glaucoma-related adverse event, consistent with the IOP-related structural changes required to diagnose glaucoma in the IATS.

Glaucoma following removal of a childhood cataract may require surgical treatment or remain medically controlled for some time, depending on its severity. Hence, surgical treatment was performed in 57% of 170 eyes with aphakic glaucoma in the large retrospective series by Chen et al,23 while Bhola et al32 noted surgical intervention in only 15 of 55 eyes (27%). At 1 year, 60% of eyes with glaucoma in the IATS received surgical intervention.13 By the 5-year visit, glaucoma medications had been used in 19 of 20 eyes (95%) diagnosed as having glaucoma and 12 of 16 (75%) diagnosed as glaucoma suspects. Surgery had been performed in 8 eyes, 1 for angle-closure glaucoma (with initial control but later retinal detachment and phthisis). Five of 7 eyes with open-angle glaucoma requiring surgery by 5 years old had that surgery in the first year after cataract removal, and they have remained controlled (eTable 3 in the Supplement). Surgery performed in the 7 eyes with open-angle glaucoma included trabeculotomy, glaucoma drainage implantation, and endoscopic diode cyclophotocoagulation, reflecting lack of uniform initial surgery chosen by different surgeons for this type of glaucoma.26

Visual acuity in children who develop glaucoma following congenital cataract surgery may be limited by glaucomatous optic nerve damage, amblyopia, pupillary membranes, corneal decompensation, or complications from glaucoma surgery. At the 5-year visit, the visual acuity differences between those eyes with vs without glaucoma did not reach statistical significance, perhaps owing to the small sample size of each group; reduced visual acuity may nonetheless develop in the glaucoma group with longer follow-up.

Limitations of this study included the relatively small sample size of the entire cohort (reducing power to adequately assess some factors), intermediate follow-up of 4.8 years following cataract surgery, and lack of study-related treatment protocols for glaucoma-related adverse events. In addition, we could not evaluate IOL position as a risk factor for glaucoma-related adverse events because most eyes had in-the-bag IOLs.33 We also could not separate out the influence of additional intraocular surgery because glaucoma-related adverse events likely affected timing of nonurgent additional surgical procedures. This study’s strengths included its prospective design with randomization to primary IOL implantation vs aphakia, as well as standardized definitions of glaucoma and glaucoma suspect.

Planned follow-up data at age 10 years for all IATS participants should provide additional important information about risk factors for the development of glaucoma and the effect of glaucoma on visual outcomes in patients with unilateral cataract. They may also help better delineate potential differences in glaucoma severity and treatment success between eyes in the IOL and CL study groups.

Corresponding Author: Sharon F. Freedman, MD, Duke Eye Center, Duke University Medical Center, 2351 Erwin Rd, Durham, NC 27710 (sharon.freedman@duke.edu).

Submitted for Publication: January 29, 2015; final revision received March 16, 2015; accepted March 19, 2015.

Published Online: May 21, 2015. doi:10.1001/jamaophthalmol.2015.1329.

Author Contributions: Drs Freedman and Lynn had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Lynn, Lambert.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Freedman, Lynn.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Lynn.

Obtained funding: Lynn, Lambert.

Administrative, technical, or material support: Lynn, Beck.

Study supervision: Freedman, Lynn, Bothun, Lambert.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Funding/Support: This study was supported by National Institutes of Health grants U10 EY13272 and U10 EY013287 and in part by National Institutes of Health Departmental Core Grant EY06360 and Research to Prevent Blindness Inc, New York, New York. Mr Lynn has received grants from the National Eye Institute. Dr Örge has received grants from the National Institutes of Health.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Information: The Infant Aphakia Treatment Study Group includes the following: Administrative Units and Participating Clinical Centers: Clinical Coordinating Center (Emory University): Scott R. Lambert, MD (study chair), and Lindreth DuBois, MEd, MMSc (national coordinator). Data Coordinating Center (Emory University): Michael Lynn, MS (director), Betsy Bridgman, BS, Marianne Celano, PhD, Julia Cleveland, MSPH, George Cotsonis, MS, Carey Drews-Botsch, PhD, Nana Freret, MSN, Lu Lu, MS, Azhar Nizam, MS, Seegar Swanson, and Thandeka Tutu-Gxashe, MPH. Vision and Developmental Testing Center (University of Alabama, Birmingham): E. Eugenie Hartmann, PhD (director); Anna K. Carrigan, MPH; and Clara Edwards. Eye Movement Reading Center (University of Alabama, Birmingham and Retina Foundation of the Southwest, Dallas, Texas): Claudio Busettini, PhD, Samuel Hayley, and Joost Felius, PhD. Steering Committee: Scott R. Lambert, MD, Edward G. Buckley, MD, David A. Plager, MD, M. Edward Wilson, MD, Michael Lynn, MS, Lindreth DuBois, Med, MMSc, Carolyn Drews-Botsch, PhD, E. Eugenie Hartmann, PhD, and Donald F. Everett, MA. Contact Lens Committee: Buddy Russell, COMT, and Michael Ward, MMSc. Participating Clinical Centers (in order by the number of patients enrolled): Medical University of South Carolina; Charleston, South Carolina (14): M. Edward Wilson, MD, and Margaret Bozic, CCRC, COA. Harvard University; Boston, Massachusetts (14): Deborah K. VanderVeen, MD, Theresa A. Mansfield, RN, and Kathryn Bisceglia Miller, OD. University of Minnesota, Minneapolis (13): Stephen P. Christiansen, MD, Erick D. Bothun, MD, Ann Holleschau, Jason Jedlicka, OD, Patricia Winters, OD, and Jacob Lang, OD. Cleveland Clinic; Cleveland, Ohio (10): Elias I. Traboulsi, MD, Susan Crowe, BS, COT, and Heather Hasley Cimino, OD. Baylor College of Medicine, Houston, Texas (10): Kimberly G. Yen, MD, Maria Castanes, MPH, Alma Sanchez, COA, and Shirley York. Oregon Health and Science University; Portland, Oregon (9): David T. Wheeler, MD, Ann U. Stout, MD, Paula Rauch, OT, CRC, Kimberly Beaudet, CO, COMT, and Pam Berg, CO, COMT. Emory University, Atlanta, Georgia (9): Scott R. Lambert, MD, Amy K. Hutchinson, MD, Lindreth DuBois, Med, MMSc, Rachel Robb, MMSc, and Marla J. Shainberg, CO. Duke University; Durham, North Carolina (8): Edward G. Buckley, MD, Sharon F. Freedman, MD, Lois Duncan, BS, B. W. Phillips, FCLSA, and John T. Petrowski, OD. Vanderbilt University: Nashville, Tennessee (8): David Morrison, MD, Sandy Owings, COA, CCRP, Ron Biernacki, CO, COMT, and Christine Franklin, COT. Indiana University (7): David A. Plager, MD, Daniel E. Neely, MD, Michele Whitaker, COT, Donna Bates, COA, and Dana Donaldson, OD. Miami Children’s Hospital (6): Stacey Kruger, MD, Charlotte Tibi, CO, and Susan Vega. University of Texas Southwestern; Dallas, Texas (6): David R. Weakley, MD, David R. Stager Jr, Joost Felius, PhD, Clare Dias, CO, Debra L. Sager, and Todd Brantley, OD. Case Western Reserve, Cleveland, Ohio (1): Faruk Örge, MD. Data and Safety Monitoring Committee: Robert Hardy, PHD (chair), Eileen Birch, PhD, Ken Cheng, MD, Richard Hertle, MD, Craig Kollman, PhD, Marshalyn Yeargin-Allsopp, MD (resigned), Cyd McDowell, and Donald F. Everett, MA. Medical Safety Monitor: Allen Beck, MD.

Previous Presentation: This study was presented in part as a paper at the American Academy of Ophthalmology 2014 Annual Scientific Meeting; October 20, 2014; Chicago, Illinois.

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Swamy  BN, Billson  F, Martin  F,  et al.  Secondary glaucoma after paediatric cataract surgery. Br J Ophthalmol. 2007;91(12):1627-1630.
PubMed   |  Link to Article
Chen  TC, Bhatia  LS, Halpern  EF, Walton  DS.  Risk factors for the development of aphakic glaucoma after congenital cataract surgery. Trans Am Ophthalmol Soc. 2006;104:241-251.
PubMed
Kuhli-Hattenbach  C, Lüchtenberg  M, Kohnen  T, Hattenbach  LO.  Risk factors for complications after congenital cataract surgery without intraocular lens implantation in the first 18 months of life. Am J Ophthalmol. 2008;146(1):1-7.
PubMed   |  Link to Article
Trivedi  RH, Wilson  ME  Jr, Golub  RL.  Incidence and risk factors for glaucoma after pediatric cataract surgery with and without intraocular lens implantation. J AAPOS. 2006;10(2):117-123.
PubMed   |  Link to Article
Wong  IB, Sukthankar  VD, Cortina-Borja  M, Nischal  KK.  Incidence of early-onset glaucoma after infant cataract extraction with and without intraocular lens implantation. Br J Ophthalmol. 2009;93(9):1200-1203.
PubMed   |  Link to Article
Kirwan  C, Lanigan  B, O’Keefe  M.  Glaucoma in aphakic and pseudophakic eyes following surgery for congenital cataract in the first year of life. Acta Ophthalmol. 2010;88(1):53-59.
PubMed   |  Link to Article
Beck  AD, Freedman  SF, Lynn  MJ, Bothun  E, Neely  DE, Lambert  SR; Infant Aphakia Treatment Study Group.  Glaucoma-related adverse events in the Infant Aphakia Treatment Study: 1-year results. Arch Ophthalmol. 2012;130(3):300-305.
PubMed   |  Link to Article
Lambert  SR, Buckley  EG, Drews-Botsch  C,  et al; Infant Aphakia Treatment Study Group.  The Infant Aphakia Treatment Study: design and clinical measures at enrollment. Arch Ophthalmol. 2010;128(1):21-27.
PubMed   |  Link to Article
Plager  DA, Lynn  MJ, Buckley  EG, Wilson  ME, Lambert  SR; Infant Aphakia Treatment Study Group.  Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study. Ophthalmology. 2011;118(12):2330-2334.
PubMed   |  Link to Article
Plager  DA, Lynn  MJ, Buckley  EG, Wilson  ME, Lambert  SR; Infant Aphakia Treatment Study Group.  Complications in the first 5 years following cataract surgery in infants with and without intraocular lens implantation in the Infant Aphakia Treatment Study. Am J Ophthalmol. 2014;158(5):892-898.
PubMed   |  Link to Article
Lambert  SR, Lynn  MJ, Hartmann  EE,  et al; Infant Aphakia Treatment Study Group.  Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: a randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years. JAMA Ophthalmol. 2014;132(6):676-682.
PubMed   |  Link to Article
Asrani  S, Freedman  S, Hasselblad  V,  et al.  Does primary intraocular lens implantation prevent “aphakic” glaucoma in children? J AAPOS. 2000;4(1):33-39.
PubMed   |  Link to Article
Mataftsi  A, Haidich  AB, Kokkali  S,  et al.  Postoperative glaucoma following infantile cataract surgery: an individual patient data meta-analysis. JAMA Ophthalmol. 2014;132(9):1059-1067.
PubMed   |  Link to Article
Sahin  A, Caça  I, Cingü  AK,  et al.  Secondary glaucoma after pediatric cataract surgery. Int J Ophthalmol. 2013;6(2):216-220.
PubMed
Lin  H, Chen  W, Luo  L,  et al; Study Group of CCPMOH.  Ocular hypertension after pediatric cataract surgery: baseline characteristics and first-year report. PLoS One. 2013;8(7):e69867.
PubMed   |  Link to Article
Egbert  JE, Wright  MM, Dahlhauser  KF, Keithahn  MA, Letson  RD, Summers  CG.  A prospective study of ocular hypertension and glaucoma after pediatric cataract surgery. Ophthalmology. 1995;102(7):1098-1101.
PubMed   |  Link to Article
Chen  TC, Walton  DS, Bhatia  LS.  Aphakic glaucoma after congenital cataract surgery. Arch Ophthalmol. 2004;122(12):1819-1825.
PubMed   |  Link to Article
Pressman  SH, Crouch  ER  Jr.  Pediatric aphakic glaucoma. Ann Ophthalmol. 1983;15(6):568-573.
PubMed
Phelps  CD, Arafat  NI.  Open-angle glaucoma following surgery for congenital cataracts. Arch Ophthalmol. 1977;95(11):1985-1987.
PubMed   |  Link to Article
World Glaucoma Association. Childhood Glaucoma: The 9th Consensus Report of the World Glaucoma Association. Amsterdam, the Netherlands: Kugler Publications; 2013.
Vishwanath  M, Cheong-Leen  R, Taylor  D, Russell-Eggitt  I, Rahi  J.  Is early surgery for congenital cataract a risk factor for glaucoma? Br J Ophthalmol. 2004;88(7):905-910.
PubMed   |  Link to Article
Lundvall  A, Zetterström  C.  Complications after early surgery for congenital cataracts. Acta Ophthalmol Scand. 1999;77(6):677-680.
PubMed   |  Link to Article
Mills  MD, Robb  RM.  Glaucoma following childhood cataract surgery. J Pediatr Ophthalmol Strabismus. 1994;31(6):355-360.
PubMed
Lambert  SR, Lynn  M, Drews-Botsch  C,  et al.  A comparison of grating visual acuity, strabismus, and reoperation outcomes among children with aphakia and pseudophakia after unilateral cataract surgery during the first six months of life. J AAPOS. 2001;5(2):70-75.
PubMed   |  Link to Article
Hartmann  EE, Lynn  MJ, Lambert  SR; Infant Aphakia Treatment Study Group.  Baseline characteristics of the Infant Aphakia Treatment Study population: predicting recognition acuity at 4.5 years of age. Invest Ophthalmol Vis Sci. 2015;56(1):388-395.
PubMed   |  Link to Article
Bhola  R, Keech  RV, Olson  RJ, Petersen  DB.  Long-term outcome of pediatric aphakic glaucoma. J AAPOS. 2006;10(3):243-248.
PubMed   |  Link to Article
Lambert  SR, Buckley  EG, Drews-Botsch  C,  et al; Infant Aphakia Treatment Study Group.  A randomized clinical trial comparing contact lens with intraocular lens correction of monocular aphakia during infancy: grating acuity and adverse events at age 1 year. Arch Ophthalmol. 2010;128(7):810-818.
PubMed   |  Link to Article

Figures

Place holder to copy figure label and caption
Figure 1.
Kaplan-Meier Curves Showing the Cumulative Probability of Glaucoma and Glaucoma + Glaucoma Suspect Against Time After Cataract Surgery

One additional child in the contact lens group had glaucoma diagnosed at 4.9 years, which increased the cumulative probability to 43% (95% CI, 12%-91%). The dashed lines represent 95% CIs.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Kaplan-Meier Curves Showing the Cumulative Probability of Glaucoma and Glaucoma + Glaucoma Suspect Against Time After Cataract Surgery According to the Treatment Assignment

CL indicates contact lens; IOL, intraocular lens.

Graphic Jump Location

Tables

Table Graphic Jump LocationTable 1.  Definitions of Glaucoma, Glaucoma Suspect, and Glaucoma-Related Adverse Event
Table Graphic Jump LocationTable 2.  Baseline Characteristics of Children in the Infant Aphakia Treatment Study vs Development of Glaucoma and Glaucoma + Glaucoma Suspect

References

Lambert  SR, Purohit  A, Superak  HM, Lynn  MJ, Beck  AD.  Long-term risk of glaucoma after congenital cataract surgery. Am J Ophthalmol. 2013;156(2):355-361.e2.
PubMed   |  Link to Article
Simon  JW, Mehta  N, Simmons  ST, Catalano  RA, Lininger  LL.  Glaucoma after pediatric lensectomy/vitrectomy. Ophthalmology. 1991;98(5):670-674.
PubMed   |  Link to Article
Egbert  JE, Christiansen  SP, Wright  MM, Young  TL, Summers  CG.  The natural history of glaucoma and ocular hypertension after pediatric cataract surgery. J AAPOS. 2006;10(1):54-57.
PubMed   |  Link to Article
Parks  MM.  Visual results in aphakic children. Am J Ophthalmol. 1982;94(4):441-449.
PubMed   |  Link to Article
Johnson  CP, Keech  RV.  Prevalence of glaucoma after surgery for PHPV and infantile cataracts. J Pediatr Ophthalmol Strabismus. 1996;33(1):14-17.
PubMed
Rabiah  PK.  Frequency and predictors of glaucoma after pediatric cataract surgery. Am J Ophthalmol. 2004;137(1):30-37.
PubMed   |  Link to Article
Swamy  BN, Billson  F, Martin  F,  et al.  Secondary glaucoma after paediatric cataract surgery. Br J Ophthalmol. 2007;91(12):1627-1630.
PubMed   |  Link to Article
Chen  TC, Bhatia  LS, Halpern  EF, Walton  DS.  Risk factors for the development of aphakic glaucoma after congenital cataract surgery. Trans Am Ophthalmol Soc. 2006;104:241-251.
PubMed
Kuhli-Hattenbach  C, Lüchtenberg  M, Kohnen  T, Hattenbach  LO.  Risk factors for complications after congenital cataract surgery without intraocular lens implantation in the first 18 months of life. Am J Ophthalmol. 2008;146(1):1-7.
PubMed   |  Link to Article
Trivedi  RH, Wilson  ME  Jr, Golub  RL.  Incidence and risk factors for glaucoma after pediatric cataract surgery with and without intraocular lens implantation. J AAPOS. 2006;10(2):117-123.
PubMed   |  Link to Article
Wong  IB, Sukthankar  VD, Cortina-Borja  M, Nischal  KK.  Incidence of early-onset glaucoma after infant cataract extraction with and without intraocular lens implantation. Br J Ophthalmol. 2009;93(9):1200-1203.
PubMed   |  Link to Article
Kirwan  C, Lanigan  B, O’Keefe  M.  Glaucoma in aphakic and pseudophakic eyes following surgery for congenital cataract in the first year of life. Acta Ophthalmol. 2010;88(1):53-59.
PubMed   |  Link to Article
Beck  AD, Freedman  SF, Lynn  MJ, Bothun  E, Neely  DE, Lambert  SR; Infant Aphakia Treatment Study Group.  Glaucoma-related adverse events in the Infant Aphakia Treatment Study: 1-year results. Arch Ophthalmol. 2012;130(3):300-305.
PubMed   |  Link to Article
Lambert  SR, Buckley  EG, Drews-Botsch  C,  et al; Infant Aphakia Treatment Study Group.  The Infant Aphakia Treatment Study: design and clinical measures at enrollment. Arch Ophthalmol. 2010;128(1):21-27.
PubMed   |  Link to Article
Plager  DA, Lynn  MJ, Buckley  EG, Wilson  ME, Lambert  SR; Infant Aphakia Treatment Study Group.  Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study. Ophthalmology. 2011;118(12):2330-2334.
PubMed   |  Link to Article
Plager  DA, Lynn  MJ, Buckley  EG, Wilson  ME, Lambert  SR; Infant Aphakia Treatment Study Group.  Complications in the first 5 years following cataract surgery in infants with and without intraocular lens implantation in the Infant Aphakia Treatment Study. Am J Ophthalmol. 2014;158(5):892-898.
PubMed   |  Link to Article
Lambert  SR, Lynn  MJ, Hartmann  EE,  et al; Infant Aphakia Treatment Study Group.  Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: a randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years. JAMA Ophthalmol. 2014;132(6):676-682.
PubMed   |  Link to Article
Asrani  S, Freedman  S, Hasselblad  V,  et al.  Does primary intraocular lens implantation prevent “aphakic” glaucoma in children? J AAPOS. 2000;4(1):33-39.
PubMed   |  Link to Article
Mataftsi  A, Haidich  AB, Kokkali  S,  et al.  Postoperative glaucoma following infantile cataract surgery: an individual patient data meta-analysis. JAMA Ophthalmol. 2014;132(9):1059-1067.
PubMed   |  Link to Article
Sahin  A, Caça  I, Cingü  AK,  et al.  Secondary glaucoma after pediatric cataract surgery. Int J Ophthalmol. 2013;6(2):216-220.
PubMed
Lin  H, Chen  W, Luo  L,  et al; Study Group of CCPMOH.  Ocular hypertension after pediatric cataract surgery: baseline characteristics and first-year report. PLoS One. 2013;8(7):e69867.
PubMed   |  Link to Article
Egbert  JE, Wright  MM, Dahlhauser  KF, Keithahn  MA, Letson  RD, Summers  CG.  A prospective study of ocular hypertension and glaucoma after pediatric cataract surgery. Ophthalmology. 1995;102(7):1098-1101.
PubMed   |  Link to Article
Chen  TC, Walton  DS, Bhatia  LS.  Aphakic glaucoma after congenital cataract surgery. Arch Ophthalmol. 2004;122(12):1819-1825.
PubMed   |  Link to Article
Pressman  SH, Crouch  ER  Jr.  Pediatric aphakic glaucoma. Ann Ophthalmol. 1983;15(6):568-573.
PubMed
Phelps  CD, Arafat  NI.  Open-angle glaucoma following surgery for congenital cataracts. Arch Ophthalmol. 1977;95(11):1985-1987.
PubMed   |  Link to Article
World Glaucoma Association. Childhood Glaucoma: The 9th Consensus Report of the World Glaucoma Association. Amsterdam, the Netherlands: Kugler Publications; 2013.
Vishwanath  M, Cheong-Leen  R, Taylor  D, Russell-Eggitt  I, Rahi  J.  Is early surgery for congenital cataract a risk factor for glaucoma? Br J Ophthalmol. 2004;88(7):905-910.
PubMed   |  Link to Article
Lundvall  A, Zetterström  C.  Complications after early surgery for congenital cataracts. Acta Ophthalmol Scand. 1999;77(6):677-680.
PubMed   |  Link to Article
Mills  MD, Robb  RM.  Glaucoma following childhood cataract surgery. J Pediatr Ophthalmol Strabismus. 1994;31(6):355-360.
PubMed
Lambert  SR, Lynn  M, Drews-Botsch  C,  et al.  A comparison of grating visual acuity, strabismus, and reoperation outcomes among children with aphakia and pseudophakia after unilateral cataract surgery during the first six months of life. J AAPOS. 2001;5(2):70-75.
PubMed   |  Link to Article
Hartmann  EE, Lynn  MJ, Lambert  SR; Infant Aphakia Treatment Study Group.  Baseline characteristics of the Infant Aphakia Treatment Study population: predicting recognition acuity at 4.5 years of age. Invest Ophthalmol Vis Sci. 2015;56(1):388-395.
PubMed   |  Link to Article
Bhola  R, Keech  RV, Olson  RJ, Petersen  DB.  Long-term outcome of pediatric aphakic glaucoma. J AAPOS. 2006;10(3):243-248.
PubMed   |  Link to Article
Lambert  SR, Buckley  EG, Drews-Botsch  C,  et al; Infant Aphakia Treatment Study Group.  A randomized clinical trial comparing contact lens with intraocular lens correction of monocular aphakia during infancy: grating acuity and adverse events at age 1 year. Arch Ophthalmol. 2010;128(7):810-818.
PubMed   |  Link to Article

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Multimedia

Supplement.

eAppendix. Methods

eTable 1. Cumulative Probability of Glaucoma and Glaucoma+Glaucoma Suspect

Over the First 5 Years of Life (Mean 4.8 Years Postcataract Surgery) in Operated Eyes Enrolled In the Infant Aphakia Treatment Study

eTable 2. Bivariate Analyses of Continuous Versions of Baseline Characteristics

of Children in the Infant Aphakia Treatment Study vs Development of Glaucoma and Glaucoma+Glaucoma Suspect

eTable 3. Eyes with Glaucoma or Glaucoma Suspect After Unilateral Cataract Removal in the Infant Aphakia Treatment Study: Clinical Information (Sorted by Diagnosis, Aphakia Treatment, and Age at Diagnosis)

eTable 4. Category of Visual Acuity at Age 4.5 Years According to Glaucoma Status at Age 5 Years

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