Ultra-Widefield Fluorescein Angiography-Based Targeted Retinal Photocoagulation Versus Conventional Panretinal Photocoagulation in the Preservation of Visual Function and Regression of Proliferative Diabetic Retinopathy

October 21, 2024 updated by: Yousaf Jamal Mahsood, Hayatabad Medical Complex
Proliferative diabetic retinopathy is a vision-threatening disease that can lead to irreversible visual loss. The treatment options for proliferative diabetic retinopathy are anti-VEGF injection and retinal photocoagulation. The study aims to compare ultra-widefield fluorescein angiography-based targeted retinal photocoagulation and panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KP
      • Peshawar, KP, Pakistan, 25000
        • Khyber Teaching Hospital Peshawar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • proliferative diabetic retinopathy (PDR) with neovascularization on the disc or elsewhere in the retina

Exclusion Criteria:

  • Participants with a history of previous history of:
  • retinal photocoagulation
  • vitreoretinal surgery
  • tractional retinal detachment
  • epiretinal membrane
  • vitreomacular traction
  • glaucoma
  • uveitis
  • media opacities like cataract, corneal opacity, vitreous hemorrhage
  • anti-VEGF injections in last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRP
Targeted Retinal Photocoagulation
Procedure: Green laser
Green Laser
Active Comparator: PRP
Panretinal Photocoagulation
Procedure: Green laser
Green Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCVA
Time Frame: 2 months
Best Corrected Visual Acuity
2 months
CMT
Time Frame: 2 months
Central Macular Thickness
2 months
MD
Time Frame: 2 months
Mean Deviation
2 months
VFI
Time Frame: 2 months
Visual Filed Index
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hayatabad Medical Complex

Collaborators

Khyber Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

October 20, 2024

First Submitted That Met QC Criteria

October 20, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 306/DME/KMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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