Effect of Dexamethasone Implant on Optic Disc

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.

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Key information

Conditions

Glaucoma and Ocular Hypertension Cranial Nerve Diseases Diabetic Macular Edema Eye Diseases Glaucoma Intravenous Drug Usage Nervous System Diseases Ocular Hypertension Optic Disk Disorders Optic Nerve Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zonguldak Bülent Ecevit Üniversitesi.

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who underwent first time intravitreal injection

Exclusion criteria

Previously received any surgery

Proliferative diabetic retinopathy

Glaucoma or glaucoma suspicion

Optic disc fatigue

Optic disc edema

Uveitis and media opacity

Blurred of image clarity

Treatment and study plan

intravitreal dexamethasone implant application

Procedure

Peripapillary 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.

Other names: The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc in Diabetic maculopathy.

Primary outcomes

Peripapillary RNFL thickness measurements

Time frame: six month

micrometer

Sponsors and collaborators

Lead sponsor

Bulent Ecevit University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Apr 25, 2019
Registry last updated: May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed