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Original Investigation |

Comparative Cost-effectiveness of the Baerveldt Implant, Trabeculectomy With Mitomycin, and Medical Treatment FREE

Richard I. Kaplan, MD1; C. Gustavo De Moraes, MD1; George A. Cioffi, MD1; Lama A. Al-Aswad, MD1; Dana M. Blumberg, MD, MPH1
[+] Author Affiliations
1Department of Ophthalmology, Edward Harkness Eye Institute, Columbia University, New York, New York
JAMA Ophthalmol. 2015;133(5):560-567. doi:10.1001/jamaophthalmol.2015.44.
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Published online

Importance  The Tube vs Trabeculectomy Trial (TVT) found that the 350-mm2 Baerveldt implant (tube) and trabeculectomy with mitomycin may be similarly effective in lowering intraocular pressure in primary open-angle glaucoma. However, to date, there are no published long-term clinical data on the cost-effectiveness of trabeculectomy with mitomycin vs tube insertion.

Objective  To assess the cost-effectiveness of these procedures compared with maximal medical treatment.

Design, Setting, and Participants  We used the Markov cohort model with a 5-year time horizon to study a hypothetical cohort of 100 000 patients who required glaucoma surgery.

Main Outcomes and Measures  Quality-adjusted life-years (QALYs) gained, costs from the societal perspective, and the incremental cost-effectiveness ratio of medical treatment, trabeculectomy, and tube insertion. Costs were identified from Medicare Current Procedural Terminology and Ambulatory Payment Classification reimbursement codes and Red Book medication costs. The QALYs were based on visual field and visual acuity outcomes. The hypothetical societal limit to resources was included using a willingness-to-pay threshold of $50 000 per QALY. Costs and utilities were discounted at 3% per year. Uncertainty was assessed using deterministic sensitivity analyses.

Results  The mean costs for medical treatment, trabeculectomy, and tube insertion were $6172, $7872 and $10 075, respectively; these amounts resulted in a cost difference of $1700 (95% CI, $1644-$1770) for medical treatment vs trabeculectomy, $3904 (95% CI, $3858-$3953) for medical treatment vs tube insertion, and $2203 (95% CI, $2121-$2261) for trabeculectomy vs tube insertion. The mean 5-year probability of blindness was 4% for both surgical procedures and 15% for medical treatment. The utility gained after medical treatment, trabeculectomy, and tube insertion was 3.10, 3.30, and 3.38 QALYs, respectively. The incremental cost-effectiveness ratio was $8289 per QALY for trabeculectomy vs medical treatment, $13 896 per QALY for tube insertion vs medical treatment, and $29 055 per QALY for tube insertion vs trabeculectomy. The cost-effectiveness of each surgical procedure was most sensitive to early and late surgical failure rates and was minimally affected by adverse events, rates of visual field progression, or medication costs.

Conclusions and Relevance  Assuming a willingness to pay of $50 000 per QALY, trabeculectomy and tube insertion are cost-effective compared with medical treatment alone. Trabeculectomy, however, is cost-effective at a substantially lower cost per QALY compared with tube insertion. More research is necessary to reliably account for patient preferences between the 2 operations.

Figures in this Article

Glaucoma is the most common cause of preventable blindness in the United States. Approximately 3 million Americans are currently affected by glaucoma, with projection of more than 6 million patients in the United States by 2050.1 Surgical intervention for glaucoma usually occurs when medical and laser therapy have failed to control intraocular pressure (IOP). The criterion standard incisional surgical procedure for glaucoma has traditionally been trabeculectomy. However, in response to growing concerns over bleb-related complications and relative lack of predictability, tube insertion operations have been increasing in popularity.2,3 Clinical trial data supported the growing preference for tubes when the Tube Versus Trabeculectomy trial (TVT)4 reported similar IOP reduction between the 2 arms.

To our knowledge, there are no published long-term clinical data on the cost-effectiveness of trabeculectomy with mitomycin vs the 350-mm2 Baerveldt implant (tube). The purpose of this study was to estimate the mean relative costs and quality of life for each surgical intervention compared with maximal medical treatment using decision analysis modeling. To do this, we created a mathematical Markov model that incorporated clinical trial data on rates of surgical success, risks of short- and long-term surgical complications, need for supplemental medication, rates of visual progression, associated medical and surgical costs, and quality of life based on visual preservation and adverse effects of surgical intervention. We have previously used similar methods to assess the effect on visual function of community glaucoma screening using spectral-domain optical coherence tomography.5

A Markov model is a computer-based algorithm that assigns each simulated patient to one of a finite number of discrete health states for a period called a cycle. At the end of each cycle, patients may remain in their health state or progress to a different health state based on probabilities that are specified for transitioning from one health state to another. All probabilities, health states, and outcomes were derived from peer-reviewed clinical trial data. The primary outcomes of our Markov model were patient utility and cost-effectiveness for each of the surgical interventions.

Decision Analytic Model

We simulated the course of 100 000 hypothetical patients with primary open-angle glaucoma treated with surgery or maximal medical treatment. The project was exempt from institutional review board approval because it did not involve human subjects, and all data were obtained from the published literature. The baseline visual field mean deviation for each simulated patient with glaucoma was randomly selected from a probability distribution function and was tracked for every year that a patient survived during the 5-year time horizon. In the first year after surgery, patients were subject to (1) the risk of early complications, (2) early failure with or without resultant visual field progression, (3) visual field progression despite surgical success, and (4) death. In subsequent years, patients were subject to (1) the risk of late complications, (2) late failure with or without resultant visual field progression, (3) visual field progression despite surgical success, and (4) death. Surgical success and visual field progression were not mutually exclusive events, although the rates of visual field progression in the surgical success states were lower than in the surgical failure states. The medical arm was subject to death and the risk of visual field progression despite maximal tolerated medical treatment.

In total, the Markov model included 10 possible health states derived from surgical status, central visual acuity, and visual field stage as defined by the Bascom Palmer glaucoma staging system; only visual acuity and visual field states applied to the medication arm (Figure 1). The model was programmed with TreeAge Pro 2012 statistical software (TreeAge Software Inc).

Place holder to copy figure label and caption
Figure 1.
Markov Model

Surgery represents the paths of trabeculectomy and tube insertion. Surgical complications and visual acuity were evaluated but are not depicted. VF indicates visual field.

Graphic Jump Location
Population

The simulated cohort had a mean age of 78 years, which reflected the mean age of patients undergoing glaucoma surgery.6,7 Age-specific mortality rates for individuals were based on US Census data.

Probability of Surgical Success

The model was calibrated to match the early and late failure rates of the trabeculectomy and tube groups presented by Gedde et al4,8 in the TVT. Failure in our model was defined as an IOP greater than 21 mm Hg with less than 20% reduction from baseline on 2 consecutive visits as defined by the TVT. Early failure rates were derived from 1-year results of the TVT.

To calculate the late annual failure rates, the overall failure rates between follow-up years 1 and 5 of the TVT were annualized by converting the 4-year probability to instantaneous rates from which 1-year probabilities were derived using the following equation: r = −[ln (1 – p)]/t, where p indicates 1 – exp {-rt}; r, rate; and t, time. Patients in whom surgical intervention failed were assumed to resume maximal medical treatment and have a greater probability of progression, which is further discussed below.

Probability of Early and Late Surgical Complications

Complications were selected only if their occurrence could result in potential visual loss or need for additional operation because of the complication itself or subsequent failure of the initial glaucoma surgery. The model included 5 early complications for the trabeculectomy group: endophthalmitis, suprachoroidal hemorrhage, bleb leak that required revision, hypotony maculopathy, or corneal edema that required penetrating keratoplasty. Likewise, the model included 5 early complications for the tube group: endophthalmitis, suprachoroidal hemorrhage, tube erosion, corneal edema that required penetrating keratoplasty, or diplopia. Probabilities for all early surgical complications were based on the 1-year results of the TVT911 (Table 1). All late complications were derived from the 5-year TVT results. Like late failure, annual results were obtained by converting the 5-year complication probability to an instantaneous rate, which was then reconverted to an annual probability. Management of complications and visual recuperation were derived from peer-reviewed publications, which is detailed in the eMethods in the Supplement.1928

Table Graphic Jump LocationTable 1.  Input Parameters for the Event Probabilities, Utilities, and Baseline Visual Field Used in the Markov Model of Surgical Intervention for Primary Open-Angle Glaucoma
Estimating Baseline Visual Field Loss and Rates of Progression

The baseline magnitude of an individual’s visual field damage was selected from a probability distribution function that was intended to reflect a cohort of potential surgical patients (Table 1). Progression was defined as a decrease of 3 dB of mean deviation of visual field loss. Annual field progression in the medical treatment arm was calculated by using the rates of progression from 2 peer-reviewed studies16,18 of eyes that required surgery but continued to receive medical treatment. Rates of progression in the surgical success arm were estimated to be 10% as derived from the work of Folgar and colleagues.16 Because no current studies have compared rates of visual field progression between eyes with successful and failed glaucoma incisional operations, visual field data were extrapolated from the work of Folgar et al and cross-validated with the visual field data from the Collaborative Initial Glaucoma Treatment Study Advanced Subgroup.17 In both studies, patients with failed surgery had a 1.50 relative risk of progression relative to patients with successful glaucoma surgery; of note, the differences in the study populations were not statistically significant (P = .10 for the Collaborative Initial Glaucoma Treatment Study and P = .22 for the study derived from the work of Folgar et al) (eMethods in the Supplement).

Estimating Medication for IOP

The mean annual number of supplemental medications was derived from the 5-year TVT data.4 Surgical failures were assigned the cost of maximal tolerated medical treatment, which was defined as all 4 medications (β-blocker, carbonic anhydrase inhibitor, α-adrenergic agonist, and prostaglandin).

Costs

The costs, in 2013 US dollars, of surgical and medical management were derived from the 2013 national Medicare reimbursement rates for Current Procedural Terminology codes and the Ambulatory Payment Classification reimbursement codes (services) as documented by the American Medical Association (code source). Medication costs were obtained from the 2013 Red Book using the lowest current price available (Table 2). Future costs were converted to net present values using a discount rate of 3% annually. The costs of initial surgery included physician and hospital outpatient reimbursement rates, including surgical costs and anesthesia, direct costs of medical management in the postoperative period, costs of medical and surgical management of adverse events, costs of supplemental IOP-lowering medications, routine glaucoma follow-up, and lost wages.

Table Graphic Jump LocationTable 2.  Costs Incorporated in the Markov Model for Surgical Intervention for Primary Open-Angle Glaucoma

Follow-up costs were derived from the preferred practice patterns and included office visits and ancillary testing. Patients with failed operations and patients with progressive disease received additional office visits with ancillary testing. Blind patients incurred costs associated with low vision aids (eMethods in the Supplement).29

Outcomes

Quality-adjusted life-years (QALYs) are a frequent measure of utility in decision analysis and cost-effectiveness modeling. The QALYs reflect a range from death to perfect health, anchored at 0 to 1, respectively, for each year of life. Utilities for visual field loss and blindness are listed in Table 1.12,14,15 In our model, the patient was assigned to the lowest utility associated with his/her ophthalmic health state. For example, one cycle in the health state, “surgical success with advanced visual field loss and moderate central visual acuity,” could be associated with 0.86 QALYs for the visual field or 0.74 QALYs for the visual acuity. Because the model assigned the lower utility, the patient gained 0.74 QALYs for that cycle. In an attempt to reflect the disutility associated with additional medical treatment30,31 and the psychological discomfort (eg, anxiety) of having had failed surgery, QALYs were reduced 10% for patients in whom surgery failed. This approach is consistent with previous ophthalmic models that have incorporated a decreased utility in patients with adverse events after surgical procedures.29

Sensitivity Analyses

Sensitivity analyses were performed to evaluate whether the uncertainty of our parameters would result in a change of projected outcome (eMethods in the Supplement). For the purposes of our deterministic sensitivity analysis, we calculated a weighted mean 1-year success rate for each of the 2 surgical procedures based on a meta-analysis of peer-reviewed trials. The 1-year tube failure rate was 7.2% as calculated from 6 peer-reviewed studies8,3236 that included all types of glaucoma. The 1-year trabeculectomy failure rate was 7.4% as derived from the results of 7 studies8,3742 in patients with primary open-angle glaucoma.

In addition, we conducted a probabilistic sensitivity analysis using Monte Carlo simulation of input parameters simultaneously (eTable 2 in the Supplement). Parameters were varied using β-distributions except for age, which had a normal distribution. For all sensitivity analyses, we used a willingness-to-pay (WTP) threshold of $50 000 per QALY to determine which intervention was best because parameters were varied. The WTP represents the amount of additional cost that the paying party (eg, government, patient, or society) is willing to pay for one QALY added.

Model Validation

Our model predicted a 4-year surgical failure rate of 34%, whereas Jampel et al43 reported a failure rate of 30% in a 4-year case series of almost 800 patients. The predicted probabilities of bleb leak and tube erosion were in keeping with reported rates from the peer-reviewed literature: 4% vs predicted 3% for bleb leak43 and 1% vs predicted 1% for tube erosion.44

Base Case

During a 5-year time horizon, the mean cost of medical treatment only was $6172, the mean cost of a trabeculectomy was $7872, and the mean cost of a tube insertion was $10 075, resulting in a difference of $1700 (95% CI, $1644-$1770) between medical treatment and trabeculectomy, $3904 (95% CI, $3858-$3953) between medical treatment and tube insertion, and $2203 (95% CI, $2121-$2261) between trabeculectomy and tube insertion. The mean 5-year probability of blindness (defined as visual field mean deviation <−23) was 4% for both surgical procedures and 15% for medical treatment. After 5 years, the mean patient-related utility gained was 3.10 QALYs after medical treatment, 3.30 QALYs after a trabeculectomy, and 3.38 QALYs after tube insertion. The incremental cost-effectiveness ratio (ICER), calculated as the additional cost per QALY gained, was $8289 per QALY for trabeculectomy relative to medical treatment, $13 896 per QALY for tube insertion relative to medical treatment, and $29 055 per QALY for tube insertion relative to trabeculectomy (eFigure 1 in the Supplement).

Sensitivity Analysis

A sensitivity analysis was performed to evaluate the effect of parameter uncertainties on the outcomes of the model (Table 3). When the rate of early failure in the trabeculectomy group was decreased to the 7.5% meta-analysis rate, the cost of trabeculectomy relative to medical treatment decreased to $6401 per QALY, and the cost of tube insertion relative to trabeculectomy increased to $40 891 per QALY. Likewise, when the tube early failure rate was increased to the calculated meta-analysis rate of 7.2%, the cost of tube insertion relative to medical treatment increased to $14 302 per QALY, and the cost of tube insertion relative to trabeculectomy increased to $31 653 per QALY. When both failure rates are incorporated into the model, the incremental cost per QALY of tube insertion relative to trabeculectomy increases to $55 223 per QALY, and tube insertion is no longer a cost-effective option when assuming a WTP of $50 000.

Table Graphic Jump LocationTable 3.  Sensitivity Analysis of Individual Microsimulation Parameters and Their Effects on the ICER for Tube Insertion and Trabeculectomy in the Markov Model of Medical and Surgical Interventions for Primary Open-Angle Glaucoma

Because the tube was most costly, we assessed the effect of varying the trabeculectomy failure rate until the cost of a tube insertion and a trabeculectomy were equal. The increased trabeculectomy failure rate would result in both additional use of medication and a higher risk of progression, resulting in increased associated costs. If all other parameters were held constant, the risk of early trabeculectomy failure would need to be 64% for the cost of a tube insertion and a trabeculectomy to be equal during a 5-year period.

We then simultaneously varied the 1-year failure rates of tube and trabeculectomy in a 2-way sensitivity analysis to determine when the trabeculectomy would become the preferred treatment option in terms of cost-effectiveness per QALY. Trabeculectomy became the preferred option when the 1-year trabeculectomy failure probability decreased to approximately 0.08 and the tube insertion 1-year failure rate increased to approximately 0.045. In this case, trabeculectomy would have an incremental gain of 0.01 QALYs, and tube insertion would have a loss of 0.02 QALYs, resulting in an ICER of $50 828 per QALY. Under this scenario and given a WTP of $50 000 per QALY, the trabeculectomy would become the favored treatment choice (eFigure 2 in the Supplement).

Several additional parameters, including rate of progression in patients with and without surgical success, additional operation after failed surgery, time horizon, QALY values, incidence of adverse events, decrease in Medicare reimbursement for tube insertion, and medical treatment costs were varied but had no significant effect on costs or utilities of either surgery (eResults in the Supplement provide the complete results of sensitivity analyses).

Probalistic Sensitivity Analysis

We varied all parameters in the interventions simultaneously to test the stability of the model (eTable 2 in the Supplement). The results of this probalistic sensitivity analysis are depicted in a cost-effectiveness acceptability curve comparing the 2 surgical procedures to medication alone (Figure 2). Trabeculectomy was more likely to be the preferred strategy at lower WTP values. Medical treatment was the preferred treatment in 100% of simulations at a WTP of $0 per QALY and 1% at $15 000 per QALY but 0% at higher WTP thresholds. Trabeculectomy was preferred in 99% of simulations at $15 000 per QALY, 33% at $45 000 per QALY, 14% at $60 000 per QALY, and 4% at $90 000 per QALY. Likewise, tube insertion was preferred in 67% at $45 000 per QALY, 86% at $60 000 per QALY, and 97% at $105 000 per QALY.

Place holder to copy figure label and caption
Figure 2.
Acceptability Curve Depicting the Probability That Trabeculectomy With Mitomycin, Baerveldt Implant, or Medical Treatment Will Be Cost-effective Given Uncertainty of All Parameters
Graphic Jump Location

The increasing popularity of tube insertions has been validated by the TVT study in terms of efficacy and complication rates. To date, no cost-effectiveness studies have compared the 2 surgical procedures with medical treatment. The intent of this study was to evaluate whether the more expensive surgical options were cost-effective. We found that the tube was more expensive and provided marginally higher utility than trabeculectomy at 5 years. When compared with medication alone, both operations were highly cost-effective.

There are at least 6 limitations of this study. First, in developing the model, several assumptions had to be made because of the relative paucity of sufficient data. Among these assumptions were (1) populating the model with early and late tube failure rates derived exclusively from the TVT studies, (2) assuming that patients in whom surgery failed later received maximum medical treatment, and (3) calibrating the model to match the relative rates of visual field progression using data that were largely derived from a single retrospective cohort study. To test these assumptions, we performed multiple sensitivity analyses but found no significant effect on costs or utilities of either surgery.

Second, our primary effectiveness outcome was quality of life. Although QALYs are a common measure of health-related utility, some experts argue that the concept of a QALY fails to accurately capture patients’ actual perceptions and preferences.45 In glaucoma research, the inherent weaknesses of the QALY as a utility measure are compounded by limited data and varying assignment of QALYs when different methodologic approaches are applied46 (the eDiscussion in the Supplement provides further discussion of QALY and WTP).

Third, additional surgical selection factors were not considered in this model. Factors such as preservation of conjunctiva for future operations, viability of conjunctiva, ophthalmic surgical history, patient adherence, and patient preference are all unaccounted for in this model.

Fourth, because the TVT study did not exclude patients with prior ophthalmic surgery, which is a known risk factor for glaucoma surgical failure,47 our model may have had an increased surgical failure rate relative to eyes that were not operated on. However, because this would be true in both surgical groups, the effects should be nondifferential and should not affect the relative cost or benefit between the 2 operations. This limitation would, however, decrease the efficacy of both operations relative to medications and would increase the ICERs of either surgery relative to medication.

Fifth, not all complications included in the TVT study were included in the model. We decided instead to include the most serious complications of surgery. Nevertheless, additional outliers may exist.

Sixth, this study primarily used data from the TVT, and therefore generalization should be done judiciously. In particular, these data may not be applicable to eyes without previous surgery. In addition, there may be differences from other implants, such as Molteno and Ahmed, or trabeculectomy with fluorouracil or without antimetabolite.

The results of this study suggest that tube insertion and trabeculectomy with mitomycin are cost-effective procedures. Quality of life and 5-year cost burden are markedly similar for tube insertion and trabeculectomy compared with medical treatment. When compared with each other, trabeculectomy had a substantially lower cost per QALY than tube insertion. In our model, tube insertion became relatively more cost-effective when rates of visual field progression after surgical failure were increased, and trabeculectomy likewise became more cost-effective when trabeculectomy failure rates were decreased from rates derived from the TVT to our calculated meta-analysis rate. Future studies should focus on rates of visual field progression after both surgical procedures.

Submitted for Publication: October 21, 2014; final revision received November 25, 2014; accepted December 15, 2014.

Corresponding Author: Dana M. Blumberg, MD, MPH, Department of Ophthalmology, Edward Harkness Eye Institute, Columbia University, 635 W 165th St, New York, NY 10032 (dmb2196@columbia.edu).

Published Online: March 5, 2015. doi:10.1001/jamaophthalmol.2015.44.

Author Contributions: Dr Blumberg had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: All authors.

Acquisition, analysis, or interpretation of data: Kaplan, Al-Aswad, Blumberg.

Drafting of the manuscript: Kaplan, De Moraes, Cioffi, Blumberg.

Critical revision of the manuscript for important intellectual content: Kaplan, De Moraes, Blumberg.

Statistical analysis: Kaplan, Blumberg.

Obtained funding: Blumberg.

Administrative, technical, or material support: Blumberg.

Study supervision: De Moraes, Cioffi, Al-Aswad, Blumberg.

Conflict of Interest Disclosures: None reported.

Funding/Support: This study was supported by grant KM1 CA 156709 from the National Cancer Institute, National Institutes of Health (Dr Blumberg).

Role of the Funder/Sponsor: The funding source 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 the decision to submit the manuscript for publication.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

National Eye Institute. Glaucoma, open-angle, statistics and data. http://www.nei.nih.gov/eyedata/glaucoma. Accessed February 27, 2014.
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WuDunn  D, Alfonso  E, Palmberg  PF.  Combined penetrating keratoplasty and trabeculectomy with mitomycin C. Ophthalmology. 1999;106(2):396-400.
PubMed   |  Link to Article
Alvarenga  LS, Mannis  MJ, Brandt  JD, Lee  WB, Schwab  IR, Lim  MC.  The long-term results of keratoplasty in eyes with a glaucoma drainage device. Am J Ophthalmol. 2004;138(2):200-205.
PubMed   |  Link to Article
Abdelaziz  A, Capó  H, Banitt  MR,  et al.  Diplopia after glaucoma: drainage device implantation. J AAPOS. 2013;17(2):192-196.
PubMed   |  Link to Article
Stein  JD, Kim  DD, Peck  WW, Giannetti  SM, Hutton  DW.  Cost-effectiveness of medications compared with laser trabeculoplasty in patients with newly diagnosed open-angle glaucoma. Arch Ophthalmol. 2012;130(4):497-505.
PubMed   |  Link to Article
Gupta  V, Srinivasan  G, Mei  SS, Gazzard  G, Sihota  R, Kapoor  KS.  Utility values among glaucoma patients: an impact on the quality of life. Br J Ophthalmol. 2005;89(10):1241-1244.
PubMed   |  Link to Article
Gupta  V, Dutta  P, Ov  M, Kapoor  KS, Sihota  R, Kumar  G.  Effect of glaucoma on the quality of life of young patients. Invest Ophthalmol Vis Sci. 2011;52(11):8433-8437.
PubMed   |  Link to Article
Barton  K, Gedde  SJ, Budenz  DL, Feuer  WJ, Schiffman  J; Ahmed Baerveldt Comparison Study Group.  The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications. Ophthalmology. 2011;118(3):435-442.
PubMed   |  Link to Article
Suhr  AW, Lim  MC, Brandt  JD, Izquierdo  JC, Willits  N.  Outcomes of fornix-based versus limbus-based conjunctival incisions for glaucoma drainage device implant. J Glaucoma. 2012;21(8):523-529.
PubMed   |  Link to Article
Christakis  PG, Kalenak  JW, Zurakowski  D,  et al.  The Ahmed Versus Baerveldt Study: one-year treatment outcomes. Ophthalmology. 2011;118(11):2180-2189.
PubMed   |  Link to Article
Lee  JJ, Park  KH, Kim  DM, Kim  TW.  Clinical outcomes of Ahmed glaucoma valve implantation using tube ligation and removable external stents. Korean J Ophthalmol. 2009;23(2):86-92.
PubMed   |  Link to Article
Roy  S, Ravinet  E, Mermoud  A.  Baerveldt implant in refractory glaucoma: long-term results and factors influencing outcome. Int Ophthalmol. 2001;24(2):93-100.
PubMed   |  Link to Article
Cillino  S, Di Pace  F, Cillino  G, Casuccio  A.  Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial. Eye (Lond). 2011;25(12):1598-1606.
PubMed   |  Link to Article
Nilforushan  N, Yadgari  M, Kish  SK, Nassiri  N.  Subconjunctival bevacizumab versus mitomycin C adjunctive to trabeculectomy. Am J Ophthalmol. 2012;153(2):352-357.e1.
PubMed   |  Link to Article
Singh  K, Mehta  K, Shaikh  NM,  et al.  Trabeculectomy with intraoperative mitomycin C versus 5-fluorouracil: prospective randomized clinical trial. Ophthalmology. 2000;107(12):2305-2309.
PubMed   |  Link to Article
Stead  RE, King  AJ.  Outcome of trabeculectomy with mitomycin C in patients with advanced glaucoma. Br J Ophthalmol. 2011;95(7):960-965.
PubMed   |  Link to Article
WuDunn  D, Cantor  LB, Palanca-Capistrano  AM,  et al.  A prospective randomized trial comparing intraoperative 5-fluorouracil vs mitomycin C in primary trabeculectomy. Am J Ophthalmol. 2002;134(4):521-528.
PubMed   |  Link to Article
Scott  IU, Greenfield  DS, Schiffman  J,  et al.  Outcomes of primary trabeculectomy with the use of adjunctive mitomycin. Arch Ophthalmol. 1998;116(3):286-291.
PubMed   |  Link to Article
Jampel  HD, Solus  JF, Tracey  PA,  et al.  Outcomes and bleb-related complications of trabeculectomy. Ophthalmology. 2012;119(4):712-722.
PubMed   |  Link to Article
Stewart  WC, Kristoffersen  CJ, Demos  CM, Fsadni  MG, Stewart  JA.  Incidence of conjunctival exposure following drainage device implantation in patients with glaucoma. Eur J Ophthalmol. 2010;20(1):124-130.
PubMed
Coast  J.  Is economic evaluation in touch with society’s health values? BMJ. 2004;329(7476):1233-1236.
PubMed   |  Link to Article
Kymes  SM.  Is it time to move beyond the QALY in vision research? Ophthalmic Epidemiol. 2014;21(2):63-65.
PubMed   |  Link to Article
Lavin  MJ, Wormald  RP, Migdal  CS, Hitchings  RA.  The influence of prior therapy on the success of trabeculectomy. Arch Ophthalmol. 1990;108(11):1543-1548.
PubMed   |  Link to Article

Figures

Place holder to copy figure label and caption
Figure 1.
Markov Model

Surgery represents the paths of trabeculectomy and tube insertion. Surgical complications and visual acuity were evaluated but are not depicted. VF indicates visual field.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Acceptability Curve Depicting the Probability That Trabeculectomy With Mitomycin, Baerveldt Implant, or Medical Treatment Will Be Cost-effective Given Uncertainty of All Parameters
Graphic Jump Location

Tables

Table Graphic Jump LocationTable 1.  Input Parameters for the Event Probabilities, Utilities, and Baseline Visual Field Used in the Markov Model of Surgical Intervention for Primary Open-Angle Glaucoma
Table Graphic Jump LocationTable 2.  Costs Incorporated in the Markov Model for Surgical Intervention for Primary Open-Angle Glaucoma
Table Graphic Jump LocationTable 3.  Sensitivity Analysis of Individual Microsimulation Parameters and Their Effects on the ICER for Tube Insertion and Trabeculectomy in the Markov Model of Medical and Surgical Interventions for Primary Open-Angle Glaucoma

References

National Eye Institute. Glaucoma, open-angle, statistics and data. http://www.nei.nih.gov/eyedata/glaucoma. Accessed February 27, 2014.
Ramulu  PY, Corcoran  KJ, Corcoran  SL, Robin  AL.  Utilization of various glaucoma surgeries and procedures in Medicare beneficiaries from 1995 to 2004. Ophthalmology. 2007;114(12):2265-2270.
PubMed   |  Link to Article
Desai  MA, Gedde  SJ, Feuer  WJ, Shi  W, Chen  PP, Parrish  RK  II.  Practice preferences for glaucoma surgery: a survey of the American Glaucoma Society in 2008. Ophthalmic Surg Lasers Imaging. 2011;42(3):202-208.
PubMed   |  Link to Article
Gedde  SJ, Schiffman  JC, Feuer  WJ, Herndon  LW, Brandt  JD, Budenz  DL; Tube Versus Trabeculectomy Study Group.  Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012;153(5):789-803.e2.
PubMed   |  Link to Article
Blumberg  DM, Vaswani  R, Nong  E, Al-Aswad  L, Cioffi  GA.  A comparative effectiveness analysis of visual field outcomes after projected glaucoma screening using SD-OCT in African American communities. Invest Ophthalmol Vis Sci. 2014;55(6):3491-3500.
PubMed   |  Link to Article
Stein  JD, Ruiz  D  Jr, Belsky  D, Lee  PP, Sloan  FA.  Longitudinal rates of postoperative adverse outcomes after glaucoma surgery among medicare beneficiaries 1994 to 2005. Ophthalmology. 2008;115(7):1109-1116.e7.
PubMed   |  Link to Article
Stein  JD, Newman-Casey  PA, Niziol  LM, Gillespie  BW, Lichter  PR, Musch  DC.  Association between the use of glaucoma medications and mortality. Arch Ophthalmol. 2010;128(2):235-240.
PubMed   |  Link to Article
Gedde  SJ, Schiffman  JC, Feuer  WJ, Herndon  LW, Brandt  JD, Budenz  DL.  Treatment outcomes in the Tube Versus Trabeculectomy study after one year of follow-up. Am J Ophthalmol. 2007;143(1):9-22.
PubMed   |  Link to Article
Gedde  SJ, Herndon  LW, Brandt  JD, Budenz  DL, Feuer  WJ, Schiffman  JC.  Surgical complications in the Tube Versus Trabeculectomy Study during the first year of follow-up. Am J Ophthalmol. 2007;143(1):23-31.
PubMed   |  Link to Article
Gedde  SJ, Herndon  LW, Brandt  JD, Budenz  DL, Feuer  WJ, Schiffman  JC; Tube Versus Trabeculectomy Study Group.  Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):804-814.e1.
PubMed   |  Link to Article
Gedde  SJ, Schiffman  JC, Feuer  WJ, Herndon  LW, Brandt  JD, Budenz  DL; Tube Versus Trabeculectomy Study Group.  Three-year follow-up of the tube versus trabeculectomy study. Am J Ophthalmol. 2009;148(5):670-684.
PubMed   |  Link to Article
Lee  BS, Kymes  SM, Nease  RF  Jr, Sumner  W, Siegfried  CJ, Gordon  MO.  The impact of anchor point on utilities for 5 common ophthalmic diseases. Ophthalmology. 2008;115(5):898-903.e4.
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Rein  DB, Wirth  KE, Johnson  CA, Lee  PP.  Estimating quality-adjusted life year losses associated with visual field deficits using methodological approaches. Ophthalmic Epidemiol. 2007;14(4):258-264.
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Brown  MM, Brown  GC, Sharma  S, Kistler  J, Brown  H.  Utility values associated with blindness in an adult population. Br J Ophthalmol. 2001;85(3):327-331.
PubMed   |  Link to Article
Brown  MM, Brown  GC, Sharma  S, Landy  J, Bakal  J.  Quality of life with visual acuity loss from diabetic retinopathy and age-related macular degeneration. Arch Ophthalmol. 2002;120(4):481-484.
PubMed   |  Link to Article
Folgar  FA, De Moraes  CG, Teng  CC, Tello  C, Ritch  R, Liebmann  JM.  Effect of successful and partly successful filtering surgery on the velocity of glaucomatous visual field progression. J Glaucoma. 2012;21(9):615-618.
PubMed   |  Link to Article
Musch  DC, Gillespie  BW, Lichter  PR, Niziol  LM, Janz  NK; CIGTS Study Investigators.  Visual field progression in the Collaborative Initial Glaucoma Treatment Study: the impact of treatment and other baseline factors. Ophthalmology. 2009;116(2):200-207.
PubMed   |  Link to Article
Bhardwaj  N, Niles  PI, Greenfield  DS,  et al.  The impact of surgical intraocular pressure reduction on visual function using various criteria to define visual field progression. J Glaucoma. 2013;22(8):632-637.
PubMed   |  Link to Article
Aaberg  TM  Jr, Flynn  HW  Jr, Schiffman  J, Newton  J.  Nosocomial acute-onset postoperative endophthalmitis survey: a 10-year review of incidence and outcomes. Ophthalmology. 1998;105(6):1004-1010.
PubMed   |  Link to Article
Reynolds  MG, Haimovici  R, Flynn  HW  Jr, DiBernardo  C, Byrne  SF, Feuer  W.  Suprachoroidal hemorrhage: clinical features and results of secondary surgical management. Ophthalmology. 1993;100(4):460-465.
PubMed   |  Link to Article
Wirostko  WJ, Han  DP, Mieler  WF, Pulido  JS, Connor  TB  Jr, Kuhn  E.  Suprachoroidal hemorrhage: outcome of surgical management according to hemorrhage severity. Ophthalmology. 1998;105(12):2271-2275.
PubMed   |  Link to Article
Tuli  SS, WuDunn  D, Ciulla  TA, Cantor  LB.  Delayed suprachoroidal hemorrhage after glaucoma filtration procedures. Ophthalmology. 2001;108(10):1808-1811.
PubMed   |  Link to Article
Budenz  DL, Chen  PP, Weaver  YK.  Conjunctival advancement for late-onset filtering bleb leaks: indications and outcomes. Arch Ophthalmol. 1999;117(8):1014-1019.
PubMed   |  Link to Article
Suñer  IJ, Greenfield  DS, Miller  MP, Nicolela  MT, Palmberg  PF.  Hypotony maculopathy after filtering surgery with mitomycin C: incidence and treatment. Ophthalmology. 1997;104(2):207-214.
PubMed   |  Link to Article
Low  SAW, Rootman  DB, Rootman  DS, Trope  GE.  Repair of eroded glaucoma drainage devices: mid-term outcomes. J Glaucoma. 2012;21(9):619-622.
PubMed   |  Link to Article
WuDunn  D, Alfonso  E, Palmberg  PF.  Combined penetrating keratoplasty and trabeculectomy with mitomycin C. Ophthalmology. 1999;106(2):396-400.
PubMed   |  Link to Article
Alvarenga  LS, Mannis  MJ, Brandt  JD, Lee  WB, Schwab  IR, Lim  MC.  The long-term results of keratoplasty in eyes with a glaucoma drainage device. Am J Ophthalmol. 2004;138(2):200-205.
PubMed   |  Link to Article
Abdelaziz  A, Capó  H, Banitt  MR,  et al.  Diplopia after glaucoma: drainage device implantation. J AAPOS. 2013;17(2):192-196.
PubMed   |  Link to Article
Stein  JD, Kim  DD, Peck  WW, Giannetti  SM, Hutton  DW.  Cost-effectiveness of medications compared with laser trabeculoplasty in patients with newly diagnosed open-angle glaucoma. Arch Ophthalmol. 2012;130(4):497-505.
PubMed   |  Link to Article
Gupta  V, Srinivasan  G, Mei  SS, Gazzard  G, Sihota  R, Kapoor  KS.  Utility values among glaucoma patients: an impact on the quality of life. Br J Ophthalmol. 2005;89(10):1241-1244.
PubMed   |  Link to Article
Gupta  V, Dutta  P, Ov  M, Kapoor  KS, Sihota  R, Kumar  G.  Effect of glaucoma on the quality of life of young patients. Invest Ophthalmol Vis Sci. 2011;52(11):8433-8437.
PubMed   |  Link to Article
Barton  K, Gedde  SJ, Budenz  DL, Feuer  WJ, Schiffman  J; Ahmed Baerveldt Comparison Study Group.  The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications. Ophthalmology. 2011;118(3):435-442.
PubMed   |  Link to Article
Suhr  AW, Lim  MC, Brandt  JD, Izquierdo  JC, Willits  N.  Outcomes of fornix-based versus limbus-based conjunctival incisions for glaucoma drainage device implant. J Glaucoma. 2012;21(8):523-529.
PubMed   |  Link to Article
Christakis  PG, Kalenak  JW, Zurakowski  D,  et al.  The Ahmed Versus Baerveldt Study: one-year treatment outcomes. Ophthalmology. 2011;118(11):2180-2189.
PubMed   |  Link to Article
Lee  JJ, Park  KH, Kim  DM, Kim  TW.  Clinical outcomes of Ahmed glaucoma valve implantation using tube ligation and removable external stents. Korean J Ophthalmol. 2009;23(2):86-92.
PubMed   |  Link to Article
Roy  S, Ravinet  E, Mermoud  A.  Baerveldt implant in refractory glaucoma: long-term results and factors influencing outcome. Int Ophthalmol. 2001;24(2):93-100.
PubMed   |  Link to Article
Cillino  S, Di Pace  F, Cillino  G, Casuccio  A.  Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial. Eye (Lond). 2011;25(12):1598-1606.
PubMed   |  Link to Article
Nilforushan  N, Yadgari  M, Kish  SK, Nassiri  N.  Subconjunctival bevacizumab versus mitomycin C adjunctive to trabeculectomy. Am J Ophthalmol. 2012;153(2):352-357.e1.
PubMed   |  Link to Article
Singh  K, Mehta  K, Shaikh  NM,  et al.  Trabeculectomy with intraoperative mitomycin C versus 5-fluorouracil: prospective randomized clinical trial. Ophthalmology. 2000;107(12):2305-2309.
PubMed   |  Link to Article
Stead  RE, King  AJ.  Outcome of trabeculectomy with mitomycin C in patients with advanced glaucoma. Br J Ophthalmol. 2011;95(7):960-965.
PubMed   |  Link to Article
WuDunn  D, Cantor  LB, Palanca-Capistrano  AM,  et al.  A prospective randomized trial comparing intraoperative 5-fluorouracil vs mitomycin C in primary trabeculectomy. Am J Ophthalmol. 2002;134(4):521-528.
PubMed   |  Link to Article
Scott  IU, Greenfield  DS, Schiffman  J,  et al.  Outcomes of primary trabeculectomy with the use of adjunctive mitomycin. Arch Ophthalmol. 1998;116(3):286-291.
PubMed   |  Link to Article
Jampel  HD, Solus  JF, Tracey  PA,  et al.  Outcomes and bleb-related complications of trabeculectomy. Ophthalmology. 2012;119(4):712-722.
PubMed   |  Link to Article
Stewart  WC, Kristoffersen  CJ, Demos  CM, Fsadni  MG, Stewart  JA.  Incidence of conjunctival exposure following drainage device implantation in patients with glaucoma. Eur J Ophthalmol. 2010;20(1):124-130.
PubMed
Coast  J.  Is economic evaluation in touch with society’s health values? BMJ. 2004;329(7476):1233-1236.
PubMed   |  Link to Article
Kymes  SM.  Is it time to move beyond the QALY in vision research? Ophthalmic Epidemiol. 2014;21(2):63-65.
PubMed   |  Link to Article
Lavin  MJ, Wormald  RP, Migdal  CS, Hitchings  RA.  The influence of prior therapy on the success of trabeculectomy. Arch Ophthalmol. 1990;108(11):1543-1548.
PubMed   |  Link to Article

Correspondence

CME


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Multimedia

Supplement.

eMethods

eResults

eDiscussion

eReferences

eTable 1. Sensitivity Analysis for Probability of Visual Field Progression in the Markov Model of Surgical Intervention for Primary Open-Angle Glaucoma

eTable 2. Probabilistic Sensitivity Analysis Parameters in Markov Model of Surgical vs Medical Intervention for Primary Open-Angle Glaucoma

eFigure 1. Costs and Total Effectiveness Over 5 Years Are Depicted for Trabeculectomy With Mitomycin and Baerveldt Tube Shunt

eFigure 2. Impact of the Probability of Failure in the First Year for Trabeculectomy and Tube Shunt

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