Effect of Dexamethasone Implant on Optic Disc

Completed

• Conditions: Diabetic Macular Edema; Optic Disk Disorders; Glaucoma and Ocular Hypertension; Intravenous Drug Usage

• Registration Number: NCT03927118
• Lead Sponsor: Bulent Ecevit University

Brief Summary

This study evaluates the effect of dexamethasone implant which is an intraocular corticosteroid on the optic nerve fibers. Retinal nerve fiber thicknesses and optic nerve head pitting rates were measured before and 6 months after the injection.

Detailed Description

Diabetic macular edema is the most frequent ocular complication of diabetes resulting in irreversible loss of vision if untreated. Dexamethasone implant implant is used to treat macular edema due to diabetes. It stay in the vitreous for 6 months after intravitreal administration.

Dexamethasone implant can lead to retinal nerve fiber layer and optic nerve damage by both increasing intraocular pressure and its direct effect on neural tissue during the effective 6-month period.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-09-01
• Study Completion: 2019-01-31
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-25
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripapillary RNFL thickness measurements	six month	micrometer

Trial Locations

Locations (1)

Zonguldak Bülent Ecevit Üniversitesi.; 🇹🇷 Zonguldak, Kozlu, Turkey