0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 54.211.190.232. Please contact the publisher to request reinstatement.
Research Letters |

Use of Autologous Serum Eyedrops for the Treatment of Ocular Surface Disease: First US Experience in a Large Population as an Insurance-Covered Benefit FREE

Cyril A. Dalmon, MD; Naveen S. Chandra, MD; Bennie H. Jeng, MD
[+] Author Affiliations

Author Affiliations: Department of Ophthalmology (Drs Dalmon and Jeng) and Francis I. Proctor Foundation (Dr Jeng), University of California, San Francisco, and Department of Ophthalmology, San Francisco General Hospital (Dr Jeng), San Francisco, and The Permanente Medical Group, Walnut Creek (Dr Chandra).


Arch Ophthalmol. 2012;130(12):1612-1613. doi:10.1001/archophthalmol.2012.1652.
Text Size: A A A
Published online

Autologous serum eyedrops (ASEs) were first reported in the treatment of ocular disease in 1975 and have since been investigated in numerous ocular surface disorders.1 There are few studies from the United States, yet we know anecdotally that ASEs are used in tertiary care centers across the country.2 The lack of publicity about ASEs in the United States is, in large part, owing to unique barriers in implementing serum eyedrops as a standard treatment modality: laboratories must follow a manufacturing protocol in compliance with regulatory measures, patients must undergo phlebotomy, and patients must cover the cost. We report here a retrospective review of the first experience with ASEs in a large US patient population as an insurance-covered benefit.

We conducted a retrospective record review of all Kaiser Permanente Northern California (KPNC) members (population base of 3.2 million) who began treatment with ASEs for various ocular surface disorders from July 1, 2009, to June 30, 2010, by 11 KPNC cornea specialists. This study population represented all patients who received ASEs for the first time during the initial year in which ASEs were a covered benefit. The serum was collected at approved KPNC laboratories and prepared by Leiter's Compounding Pharmacy, San Jose, California. Institutional review board approval was granted by KPNC and the University of California, San Francisco Committee on Human Research.

Of the 103 patients treated during the study period, 18 were excluded because of prior use of ASEs and 12 were excluded for insufficient medical records, leaving 73 patients included in the study. There were 55 women and 18 men, with a mean age of 65 years. Sixty-nine patients received ASEs at a concentration of 100%. While many diseases were treated with ASEs, the leading indication for use was dry eye (Table). Among these patients with dry eye, who were typically recalcitrant to other treatments and often had concurrent indications, we identified 30 patients who had a follow-up visit within 90 days of initiating treatment with ASEs. In this group, 16 patients at the first follow-up visit and 11 at the last visit reported an improvement in symptoms with ASEs (average duration of treatment with ASEs, 8.8 months). Improved corneal staining was noted in 12 of these patients at the follow-up visit and in 13 at the last visit with ASEs. Additionally, topical lubrication use in this group decreased from 25 patients at the initial visit to 15 patients at the follow-up, and topical steroid use decreased from 10 patients to 5 patients (Figure).

Place holder to copy figure label and caption
Graphic Jump Location

Figure. Other ocular surface treatment modalities used by 30 patients with dry eye who had a follow-up within 90 days of starting treatment with autologous serum eyedrops (ASEs).

Table Graphic Jump LocationTable. Indications for Treatment With Autologous Serum Eyedrops

Seven of the 10 patients with persistent epithelial defects healed with the use of ASEs. The defect had been present for an average of 63 days prior to starting ASEs, and they healed within an average of 42 days. Of the 3 patients whose conditions did not resolve, 2 had perforation during the study period and 1 was lost to follow-up. We did not find a correlation between the duration of the defect prior to use of ASEs and the time to resolution (R2 = 0.07). Two patients reported transient discomfort with use of the ASEs.

We believe this represents the first study in which ASEs have been introduced as an insurance-covered benefit to a large and diverse US patient population. Our review supports previous reports on the safety and efficacy of ASEs, as many patients with recalcitrant dry eye symptoms improved with treatment by ASEs and used fewer local treatments.26 The continued availability of ASEs may lower the threshold for KPNC members to receive ASEs, and further studies will provide us with information as to whether patients with less advanced disease or who receive earlier treatment derive as much benefit as those who are recalcitrant to standard treatment modalities.

Correspondence: Dr Chandra, The Permanente Medical Group, 320 Lennon Ln, Walnut Creek, CA 94598 (nschandra@gmail.com).

Author Contributions: Dr Chandra 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.

Conflict of Interest Disclosures: None reported.

Ralph RA, Doane MG, Dohlman CH. Clinical experience with a mobile ocular perfusion pump.  Arch Ophthalmol. 1975;93(10):1039-1043
PubMed   |  Link to Article
Jeng BH, Dupps WJ Jr. Autologous serum 50% eyedrops in the treatment of persistent corneal epithelial defects.  Cornea. 2009;28(10):1104-1108
PubMed   |  Link to Article
Tananuvat N, Daniell M, Sullivan LJ,  et al.  Controlled study of the use of autologous serum in dry eye patients.  Cornea. 2001;20(8):802-806
PubMed   |  Link to Article
Kojima T, Ishida R, Dogru M,  et al.  The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study.  Am J Ophthalmol. 2005;139(2):242-246
PubMed   |  Link to Article
Noble BA, Loh RSK, MacLennan S,  et al.  Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease.  Br J Ophthalmol. 2004;88(5):647-652
PubMed   |  Link to Article
Lee GA, Chen SX. Autologous serum in the management of recalcitrant dry eye syndrome.  Clin Experiment Ophthalmol. 2008;36(2):119-122
PubMed   |  Link to Article

Figures

Place holder to copy figure label and caption
Graphic Jump Location

Figure. Other ocular surface treatment modalities used by 30 patients with dry eye who had a follow-up within 90 days of starting treatment with autologous serum eyedrops (ASEs).

Tables

Table Graphic Jump LocationTable. Indications for Treatment With Autologous Serum Eyedrops

References

Ralph RA, Doane MG, Dohlman CH. Clinical experience with a mobile ocular perfusion pump.  Arch Ophthalmol. 1975;93(10):1039-1043
PubMed   |  Link to Article
Jeng BH, Dupps WJ Jr. Autologous serum 50% eyedrops in the treatment of persistent corneal epithelial defects.  Cornea. 2009;28(10):1104-1108
PubMed   |  Link to Article
Tananuvat N, Daniell M, Sullivan LJ,  et al.  Controlled study of the use of autologous serum in dry eye patients.  Cornea. 2001;20(8):802-806
PubMed   |  Link to Article
Kojima T, Ishida R, Dogru M,  et al.  The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study.  Am J Ophthalmol. 2005;139(2):242-246
PubMed   |  Link to Article
Noble BA, Loh RSK, MacLennan S,  et al.  Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease.  Br J Ophthalmol. 2004;88(5):647-652
PubMed   |  Link to Article
Lee GA, Chen SX. Autologous serum in the management of recalcitrant dry eye syndrome.  Clin Experiment Ophthalmol. 2008;36(2):119-122
PubMed   |  Link to Article

Correspondence

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).
Submit a Comment

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Topics
PubMed Articles