Faculty Collaboration Database

Evaluation of the safety and performance of an applicator for a novel intravitreal dexamethasone drug delivery system for the treatment of macular edema. Retina 2009 Jan;29(1):46-51

Date

10/02/2008

Pubmed ID

18827732

DOI

10.1097/IAE.0b013e318188c814

Scopus ID

2-s2.0-61549134800 (requires institutional sign-in at Scopus site)   97 Citations

Abstract

PURPOSE: Evaluation of safety and performance of an applicator-inserted dexamethasone drug delivery system.

METHODS: Patients with clinically observable macular edema were randomized to receive 700 microg dexamethasone drug delivery system via a pars plana incisional placement (n = 10) or a 22-gauge applicator insertion (n = 20). Outcome measures included assessment of procedure duration, the postinsertion wound, adverse events, intraocular pressure, and best-corrected visual acuity at baseline and days 1, 7, 14, 30, 60, 90, and 180.

RESULTS: Both procedures were well tolerated and none of the patients in the applicator group required sutures to close the insertion wound. The overall incidence of ocular adverse events was less in the applicator group (13/19; 68.4%) than the incisional group (9/10; 90%), although the difference was not statistically significant in this pilot study. Vitreous hemorrhage occurred in two patients in the incisional group and none in the applicator group. Increases in intraocular pressure were less frequent in the applicator group (3/19; 15.8%) than the incisional group (3/10; 30%). No cases of endophthalmitis or retinal detachment occurred in either group. The percentage of patients achieving improvement in visual acuity of >/=15-letters at Day 90 was similar in both groups; 40% (8/20) in the applicator group and 30% (3/10) in the incisional group.

CONCLUSION: The dexamethasone drug delivery system applicator system performed well, allowing safe, effective, and sutureless intravitreal placement of 700 microg dexamethasone drug delivery system.

Author List

Haller JA, Dugel P, Weinberg DV, Chou C, Whitcup SM

Author

David V. Weinberg MD Emeritus Professor in the Ophthalmology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aged, 80 and over
Dexamethasone
Drug Delivery Systems
Female
Follow-Up Studies
Glucocorticoids
Humans
Intraocular Pressure
Macular Edema
Male
Middle Aged
Prospective Studies
Visual Acuity
Vitreous Body
Wound Healing