Clinical Trials Directory

Trials / Completed

CompletedNCT03927118

Effect of Dexamethasone Implant on Optic Disc

The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc Morphology in Patients With Diabetic Maculopathy

Status
Completed
Phase
Study type
Observational
Enrollment
43 (actual)
Sponsor
Bulent Ecevit University · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREintravitreal dexamethasone implant applicationPeripapillary RNFL thickness measurements and colored fundus photographs were compared before and 6 months after intravitreal DEX implant injection. The cup-to-disc ratios of fundus photographs were calculated using the Image-J program.

Timeline

Start date
2018-02-01
Primary completion
2018-09-01
Completion
2019-01-31
First posted
2019-04-25
Last updated
2019-05-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03927118. Inclusion in this directory is not an endorsement.