Evaluation of the Pain and Visual Outcome Associated With Location of Intravitreal Bevacizumab Injection
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 1,004
- Locations
- 1
- Primary Endpoint
- Pain
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Injection Anti-VEGF in quadrant 1
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1
Intervention: Anti-VEGF in quadrant 1 (Drug)
Injection Anti-VEGF in quadrant 2
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2
Intervention: Anti-VEGF in quadrant 2 (Drug)
InjectionAnti-VEGF in quadrant 3
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3
Intervention: Anti-VEGF in quadrant 3 (Drug)
InjectionAnti-VEGF in quadrant 4
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4
Intervention: Anti-VEGF in quadrant 4 (Drug)
Outcomes
Primary Outcomes
Pain
Time Frame: immediately after Intravitreal Bevacizumab Injection
Visual Analog Scale (VAS)
Secondary Outcomes
- Best-corrected visual acuity (BCVA)(preoperative and 1 month postoperatively.)
Investigators
Zahra Rabbani Khah
Ophthalmic Research center
Shahid Beheshti University of Medical Sciences