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Pain and Visual Outcome in Intravitreal Bevacizumab Injection

NCT02790775 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1004

Last updated 2017-08-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Anti-VEGF in quadrant 1

DRUG

Anti-VEGF in quadrant 2

DRUG

Anti-VEGF in quadrant 3

DRUG

Anti-VEGF in quadrant 4

Sponsors & Collaborators

  • Shahid Beheshti University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-05-30
Completion
2016-08-30

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02790775 on ClinicalTrials.gov