search
Back to results

Pain and Visual Outcome in Intravitreal Bevacizumab Injection (pain & visual)

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Anti-VEGF in quadrant 1
Anti-VEGF in quadrant 2
Anti-VEGF in quadrant 3
Anti-VEGF in quadrant 4
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Islamic Republic of Iran

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Injection Anti-VEGF in quadrant 1

Injection Anti-VEGF in quadrant 2

InjectionAnti-VEGF in quadrant 3

InjectionAnti-VEGF in quadrant 4

Arm Description

Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1

Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2

Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3

Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4

Outcomes

Primary Outcome Measures

Pain
Visual Analog Scale (VAS)

Secondary Outcome Measures

Best-corrected visual acuity (BCVA)
using Snellen chart

Full Information

First Posted
June 1, 2016
Last Updated
August 29, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02790775
Brief Title
Pain and Visual Outcome in Intravitreal Bevacizumab Injection
Acronym
pain & visual
Official Title
Evaluation of the Pain and Visual Outcome Associated With Location of Intravitreal Bevacizumab Injection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 30, 2016 (Actual)
Study Completion Date
August 30, 2016 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1004 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection Anti-VEGF in quadrant 1
Arm Type
Active Comparator
Arm Description
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1
Arm Title
Injection Anti-VEGF in quadrant 2
Arm Type
Active Comparator
Arm Description
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2
Arm Title
InjectionAnti-VEGF in quadrant 3
Arm Type
Active Comparator
Arm Description
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3
Arm Title
InjectionAnti-VEGF in quadrant 4
Arm Type
Active Comparator
Arm Description
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF in quadrant 1
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF in quadrant 2
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF in quadrant 3
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF in quadrant 4
Primary Outcome Measure Information:
Title
Pain
Description
Visual Analog Scale (VAS)
Time Frame
immediately after Intravitreal Bevacizumab Injection
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity (BCVA)
Description
using Snellen chart
Time Frame
preoperative and 1 month postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Islamic Republic of Iran
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Pain and Visual Outcome in Intravitreal Bevacizumab Injection

We'll reach out to this number within 24 hrs