Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

June 28, 2016 updated by: Chung-yee Chung, United Christian Hospital

Single-session Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy - a Randomized Study

A randomized study to assess the safety and efficacy of single-session pan-retinal photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic retinopathy (PDR) - 1,700 shots vs 2,500 shots

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All treatment-naïve patients with proliferative diabetic retinopathy (PDR) who attended our ophthalmic clinic from 1st December 2012 to 30th November

Exclusion Criteria:

  • significant media opacity affecting laser uptake (e.g. corneal opacity, mature cataract, dense vitreous haemorrhage)
  • any pre-existing ocular disorders resulting in visual impairment (e.g. retinal degenerations, maculopathies, primary glaucoma and other optic neuropathies)
  • those who received previous retinal laser treatment, intravitreal injections or intraocular surgeries
  • clinically significant macular oedema on clinical examination.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1,700
Patients receive 1,700 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser
Device: Pan-retinal photocoagulation using pattern scanning laser
Patients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session
Active Comparator: 2,500
Patients receive 2,500 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser
Device: Pan-retinal photocoagulation using pattern scanning laser
Patients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression of neovascularization
Time Frame: 3 months
Fluorescein angiogram assessment by independent observer
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity of neovascularization
Time Frame: 3 months
Descriptive analysis of fundus fluorescein angiogram by independent observer into 4 categories: no leakage, reduced leakage, same leakage, increased leakage
3 months
Best corrected visual acuity
Time Frame: 1 week, 1 month, 3 months, 6 months
1 week, 1 month, 3 months, 6 months
Complications
Time Frame: 1 week, 1 month, 3 months, 6 months
choroidal detachment, exudative retinal detachment, retinal breaks
1 week, 1 month, 3 months, 6 months
Central foveal thickness
Time Frame: 1 week
Measured by spectral domain optical coherence tomography (Heidelberg Spectralis)
1 week
Retreatment rate
Time Frame: 6 months
Patients requiring retreatment with pan-retinal photocoagulation
6 months

Collaborators and Investigators

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

Sponsor

United Christian Hospital

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: Kenneth KW Li, MBChB, United Christian Hospital; The University of Hong Kong

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

December 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-0079

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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