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Effect of Dexamethasone Implant on Optic Disc

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03927118
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : May 13, 2019
Information provided by (Responsible Party):
Atilla Alpay, Bulent Ecevit University

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 Intervention/treatment
Glaucoma and Ocular Hypertension Diabetic Macular Edema Intravenous Drug Usage Optic Disk Disorders Procedure: intravitreal dexamethasone implant application

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.

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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 1, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : January 31, 2019

Intervention Details:
  • Procedure: intravitreal 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.
    Other Name: The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc in Diabetic maculopathy.

Primary Outcome Measures :
  1. Peripapillary RNFL thickness measurements [ Time Frame: six month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Individuals over 20 years of age were included in the study.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Diabetic patient group will be included in the study.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03927118

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Zonguldak Bülent Ecevit Üniversitesi.
Zonguldak, Kozlu, Turkey, 67600
Sponsors and Collaborators
Bulent Ecevit University
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Study Director: Atilla Alpay, Ass. Prf. Zonguldak Bulent Ecevit University

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Responsible Party: Atilla Alpay, Associate professor, Bulent Ecevit University Identifier: NCT03927118    
Other Study ID Numbers: BulentEU2
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Atilla Alpay, Bulent Ecevit University:
Diabetic maculopathy
dexamethasone implant
optic disc
vascular endothelial growth factor
Additional relevant MeSH terms:
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Optic Nerve Diseases
Macular Edema
Ocular Hypertension
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Cranial Nerve Diseases
Nervous System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action