Clinical trial NCT03927118: Effect of Dexamethasone Implant on Optic Disc
Official title: The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc Morphology in Patients With Diabetic Maculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma and Ocular Hypertension
Diabetic Macular Edema
Intravenous Drug Usage
Optic Disk Disorders
Keywords: Diabetic maculopathy
dexamethasone implant
optic disc
vascular endothelial growth factor
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patient group will be included in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peripapillary RNFL thickness measurements
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit Üniversitesi.
state: Kozlu
Study officials:
affiliation: Zonguldak Bulent Ecevit University
name: Atilla Alpay, Ass. Prf.
role: STUDY_DIRECTOR
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