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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03927118
Enrollment
43
Registered
2019-04-25
Start date
2018-02-01
Completion date
2019-01-31
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Glaucoma and Ocular Hypertension, Intravenous Drug Usage, Optic Disk Disorders

Keywords

Diabetic maculopathy, dexamethasone implant, optic disc, vascular endothelial growth factor

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.

Interventions

PROCEDUREintravitreal dexamethasone implant application

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.

Sponsors

Bulent Ecevit University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Peripapillary RNFL thickness measurementssix monthmicrometer

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026