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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Effect of Dexamethasone Implant on Optic Disc

Clinicaltrials.gov identifier NCT03927118

Recruitment Status Completed

First Posted April 25, 2019

Last update posted May 13, 2019

Study Description

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.

  • Condition or Disease:Glaucoma and Ocular Hypertension
    Diabetic Macular Edema
    Intravenous Drug Usage
    Optic Disk Disorders
  • Intervention/Treatment: Procedure: intravitreal dexamethasone implant application
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 43 participants
  • Observational Model: Case-Control
  • Time Perspective: Prospective
  • Official Title: The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc Morphology in Patients With Diabetic Maculopathy
  • Actual Study Start Date: February 2018
  • Actual Primary Completion Date: September 2018
  • Actual Study Completion Date: January 2019
Outcome Measures
  • Primary Outcome Measures: 1. Peripapillary RNFL thickness measurements [ Time Frame: six month ]
    micrometer
Eligibility Criteria
  • Ages Eligible for Study: 20 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: Diabetic patient group will be included in the study.
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

Contacts and Locations
Contacts
Locations

Turkey, Kozlu
Zonguldak Bülent Ecevit Üniversitesi.
Zonguldak

Sponsors and Collaborators

Bulent Ecevit University

Investigators

Study Director: Atilla Alpay, Ass. Prf. Zonguldak Bulent Ecevit University

More Information