Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion

Study Overview
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Brief Summary
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Several studies have indicated a relation between the development of RVO and elevated intraocular pressure (IOP) and glaucoma [9]. Further investigations into the structural alterations in the fellow eyes of individuals with unilateral RVO have revealed that the pRNFL is thinner than in healthy eyes, suggesting that there may be systemic risk factors for both RVO and glaucoma

Official Title
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Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion

Conditions
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Branch Retinal Vein Occlusion

Intervention / Treatment
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* Drug: aflibercept (2mg/0.05ml)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with unilateral BRVO Exclusion Criteria: History of retinal and/or optic nerve diseases involving glaucomatous optic disc, ischemic optic neuropathy, or optic neuritis. History of trauma, intravitreal injections, vitreoretinal surgeries, and retinal or macular lasers. A significant media opacity that makes it difficult to capture clear images. No history of diabetes and/or hypertension in those recruited as the control group

Ages Eligible for Study
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Minimum Age: 47 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with unilateral BRVO<br> | Drug: aflibercept (2mg/0.05ml)<br>* Aflibercept is a medication used to treat and manage neovascular age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization, macular edema associated with retinal vein occlusion, and diabetic retinopathy. It is in the vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) antagonist class of medications. Aflibercept acts as a soluble protein decoy for VEGF receptors to inhibit the predominant signaling pathway responsible for angiogenesis and vascular leakage. Aflibercept and other anti-VEGF inhibitors have become the gold standard in controlling neovascular (wet) age-related macular degeneration (NVAMD). T<br>|
| No Intervention: Healthy individuals<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peri-papillary retinal nerve fiber layer thickness | Layer of the retina. The thickness was measured by Optical Coherence Tomography | Base line | 
| peri-papillary retinal nerve fiber layer thickness | Layer of the retina. The thickness was measured by Optical Coherence Tomography | 6 months post injection | 
| peri-papillary retinal nerve fiber layer thickness | Layer of the retina. The thickness was measured by Optical Coherence Tomography | 12 months post injection | 
| peri-papillary retinal nerve fiber layer thickness | Layer of the retina. The thickness was measured by Optical Coherence Tomography | 24 months post injection |