Two clinical trials of an intraocular steroid delivery system for cataract surgery

D. F. Chang, V. Wong, N. A. Rao, Jose S Pulido, R. L. Lindstrom, G. A. Stern, W. M. Bourne, A. J. Flach, J. T. Flynn, J. C. Borrow, W. R. Green

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Purpose: To determine the safety and efficacy of an intraocular dexamethasone drug delivery system (Surodex) in the treatment of inflammation following cataract surgery. Methods: Surodex is a biodegradable polymer that releases dexamethasone for 7 to 10 days after placement in the anterior segment. Study 1 was a prospective, randomized, double-masked Phase II clinical trial of 90 cataract surgical patients that compared treatment with Surodex to treatment with a placebo drug delivery system and to no anti- inflammatory drug treatment at all. Study 2 was a separate prospective, randomized, double-masked study of 60 cataract surgical patients that compared treatment with Surodex to topical dexamethasone (eye drop) therapy. Results: In the first study, Surodex was superior to placebo in suppressing postsurgical inflammation throughout the 60-day postoperative period, as judged by masked-evaluator, slit-lamp grading of cell and flare. The differences were statistically significant from postoperative day 3 through postoperative week 3. The majority of Surodex patients did not require topical steroid by 2 weeks after surgery (93%) or by 2 months after surgery (88%). In the second study, Kowa laser flare meter readings were lower in Surodex patients throughout the 90-day postoperative period. The results were statistically significant at 4, 8, and 15 days following surgery. There were no significant adverse complications of Surodex in either study. Conclusion: Surodex was safe and effective in suppressing postcataract surgery inflammation and appears to be a promising alternative to topical steroids.

Original languageEnglish (US)
Pages (from-to)261-279
Number of pages19
JournalTransactions of the American Ophthalmological Society
Volume97
StatePublished - 1999
Externally publishedYes

Fingerprint

Cataract
Steroids
Clinical Trials
Dexamethasone
Drug Delivery Systems
Inflammation
Postoperative Period
Therapeutics
Placebos
Phase II Clinical Trials
Ophthalmic Solutions
Ambulatory Surgical Procedures
Double-Blind Method
Reading
Polymers
Lasers
Anti-Inflammatory Agents
Safety
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Chang, D. F., Wong, V., Rao, N. A., Pulido, J. S., Lindstrom, R. L., Stern, G. A., ... Green, W. R. (1999). Two clinical trials of an intraocular steroid delivery system for cataract surgery. Transactions of the American Ophthalmological Society, 97, 261-279.

Two clinical trials of an intraocular steroid delivery system for cataract surgery. / Chang, D. F.; Wong, V.; Rao, N. A.; Pulido, Jose S; Lindstrom, R. L.; Stern, G. A.; Bourne, W. M.; Flach, A. J.; Flynn, J. T.; Borrow, J. C.; Green, W. R.

In: Transactions of the American Ophthalmological Society, Vol. 97, 1999, p. 261-279.

Research output: Contribution to journalArticle

Chang, DF, Wong, V, Rao, NA, Pulido, JS, Lindstrom, RL, Stern, GA, Bourne, WM, Flach, AJ, Flynn, JT, Borrow, JC & Green, WR 1999, 'Two clinical trials of an intraocular steroid delivery system for cataract surgery', Transactions of the American Ophthalmological Society, vol. 97, pp. 261-279.
Chang, D. F. ; Wong, V. ; Rao, N. A. ; Pulido, Jose S ; Lindstrom, R. L. ; Stern, G. A. ; Bourne, W. M. ; Flach, A. J. ; Flynn, J. T. ; Borrow, J. C. ; Green, W. R. / Two clinical trials of an intraocular steroid delivery system for cataract surgery. In: Transactions of the American Ophthalmological Society. 1999 ; Vol. 97. pp. 261-279.
@article{b89c5f4279814930a16c53e51b1703df,
title = "Two clinical trials of an intraocular steroid delivery system for cataract surgery",
abstract = "Purpose: To determine the safety and efficacy of an intraocular dexamethasone drug delivery system (Surodex) in the treatment of inflammation following cataract surgery. Methods: Surodex is a biodegradable polymer that releases dexamethasone for 7 to 10 days after placement in the anterior segment. Study 1 was a prospective, randomized, double-masked Phase II clinical trial of 90 cataract surgical patients that compared treatment with Surodex to treatment with a placebo drug delivery system and to no anti- inflammatory drug treatment at all. Study 2 was a separate prospective, randomized, double-masked study of 60 cataract surgical patients that compared treatment with Surodex to topical dexamethasone (eye drop) therapy. Results: In the first study, Surodex was superior to placebo in suppressing postsurgical inflammation throughout the 60-day postoperative period, as judged by masked-evaluator, slit-lamp grading of cell and flare. The differences were statistically significant from postoperative day 3 through postoperative week 3. The majority of Surodex patients did not require topical steroid by 2 weeks after surgery (93{\%}) or by 2 months after surgery (88{\%}). In the second study, Kowa laser flare meter readings were lower in Surodex patients throughout the 90-day postoperative period. The results were statistically significant at 4, 8, and 15 days following surgery. There were no significant adverse complications of Surodex in either study. Conclusion: Surodex was safe and effective in suppressing postcataract surgery inflammation and appears to be a promising alternative to topical steroids.",
author = "Chang, {D. F.} and V. Wong and Rao, {N. A.} and Pulido, {Jose S} and Lindstrom, {R. L.} and Stern, {G. A.} and Bourne, {W. M.} and Flach, {A. J.} and Flynn, {J. T.} and Borrow, {J. C.} and Green, {W. R.}",
year = "1999",
language = "English (US)",
volume = "97",
pages = "261--279",
journal = "Transactions of the American Ophthalmological Society",
issn = "0065-9533",
publisher = "American Ophthalmological Society",

}

TY - JOUR

T1 - Two clinical trials of an intraocular steroid delivery system for cataract surgery

AU - Chang, D. F.

AU - Wong, V.

AU - Rao, N. A.

AU - Pulido, Jose S

AU - Lindstrom, R. L.

AU - Stern, G. A.

AU - Bourne, W. M.

AU - Flach, A. J.

AU - Flynn, J. T.

AU - Borrow, J. C.

AU - Green, W. R.

PY - 1999

Y1 - 1999

N2 - Purpose: To determine the safety and efficacy of an intraocular dexamethasone drug delivery system (Surodex) in the treatment of inflammation following cataract surgery. Methods: Surodex is a biodegradable polymer that releases dexamethasone for 7 to 10 days after placement in the anterior segment. Study 1 was a prospective, randomized, double-masked Phase II clinical trial of 90 cataract surgical patients that compared treatment with Surodex to treatment with a placebo drug delivery system and to no anti- inflammatory drug treatment at all. Study 2 was a separate prospective, randomized, double-masked study of 60 cataract surgical patients that compared treatment with Surodex to topical dexamethasone (eye drop) therapy. Results: In the first study, Surodex was superior to placebo in suppressing postsurgical inflammation throughout the 60-day postoperative period, as judged by masked-evaluator, slit-lamp grading of cell and flare. The differences were statistically significant from postoperative day 3 through postoperative week 3. The majority of Surodex patients did not require topical steroid by 2 weeks after surgery (93%) or by 2 months after surgery (88%). In the second study, Kowa laser flare meter readings were lower in Surodex patients throughout the 90-day postoperative period. The results were statistically significant at 4, 8, and 15 days following surgery. There were no significant adverse complications of Surodex in either study. Conclusion: Surodex was safe and effective in suppressing postcataract surgery inflammation and appears to be a promising alternative to topical steroids.

AB - Purpose: To determine the safety and efficacy of an intraocular dexamethasone drug delivery system (Surodex) in the treatment of inflammation following cataract surgery. Methods: Surodex is a biodegradable polymer that releases dexamethasone for 7 to 10 days after placement in the anterior segment. Study 1 was a prospective, randomized, double-masked Phase II clinical trial of 90 cataract surgical patients that compared treatment with Surodex to treatment with a placebo drug delivery system and to no anti- inflammatory drug treatment at all. Study 2 was a separate prospective, randomized, double-masked study of 60 cataract surgical patients that compared treatment with Surodex to topical dexamethasone (eye drop) therapy. Results: In the first study, Surodex was superior to placebo in suppressing postsurgical inflammation throughout the 60-day postoperative period, as judged by masked-evaluator, slit-lamp grading of cell and flare. The differences were statistically significant from postoperative day 3 through postoperative week 3. The majority of Surodex patients did not require topical steroid by 2 weeks after surgery (93%) or by 2 months after surgery (88%). In the second study, Kowa laser flare meter readings were lower in Surodex patients throughout the 90-day postoperative period. The results were statistically significant at 4, 8, and 15 days following surgery. There were no significant adverse complications of Surodex in either study. Conclusion: Surodex was safe and effective in suppressing postcataract surgery inflammation and appears to be a promising alternative to topical steroids.

UR - http://www.scopus.com/inward/record.url?scp=0033368282&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033368282&partnerID=8YFLogxK

M3 - Article

C2 - 10703128

AN - SCOPUS:0033368282

VL - 97

SP - 261

EP - 279

JO - Transactions of the American Ophthalmological Society

JF - Transactions of the American Ophthalmological Society

SN - 0065-9533

ER -