Pain and Visual Outcome in Intravitreal Bevacizumab Injection

Study Overview
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Brief Summary
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In this double blind clinical trial, 1000 patients suffering from diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included. Those with the history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness measurements using optical coherence tomography (OCT). Patients are randomly assigned to each group .Each participant receive one injection in one eye in this study. Pain is measured by subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA and OCT would be checked again at month one.

Official Title
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Evaluation of the Pain and Visual Outcome Associated With Location of Intravitreal Bevacizumab Injection

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Anti-VEGF in quadrant 1
* Drug: Anti-VEGF in quadrant 2
* Drug: Anti-VEGF in quadrant 3
* Drug: Anti-VEGF in quadrant 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions Exclusion Criteria: history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS)

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Injection Anti-VEGF in quadrant 1<br>Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1 | Drug: Anti-VEGF in quadrant 1<br> <br> |
| Active Comparator: Injection Anti-VEGF in quadrant 2<br>Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2 | Drug: Anti-VEGF in quadrant 2<br> <br> |
| Active Comparator: InjectionAnti-VEGF in quadrant 3<br>Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3 | Drug: Anti-VEGF in quadrant 3<br> <br> |
| Active Comparator: InjectionAnti-VEGF in quadrant 4<br>Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4 | Drug: Anti-VEGF in quadrant 4<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Visual Analog Scale (VAS) | immediately after Intravitreal Bevacizumab Injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity (BCVA) | using Snellen chart | preoperative and 1 month postoperatively. |