Comparison of Different Fluence Settings for Yellow Subthreshold Laser Treatment in Diabetic Macular Edema

June 18, 2018 updated by: Dr Jay Chhablani, L.V. Prasad Eye Institute

To Assess the Safety and Efficacy of Two Subthreshold Parameters (5% and 15% Duty Cycle (DC)) Compared to Standard ETDRS (Early Treatment of Diabetic Retinopathy Study) Continuous Wave (CW) Laser

To assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS (early treatment of diabetic retinopathy study) continuous wave (CW) laser

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Test burn up to barely visible burn with micropulse laser, then reduce the power by 70% and perform laser with various DC (5%, 15%, cw) as per the group.

Focal to Mas+ confluent burns to areas of diffuse leakage

Study Type

Observational

Enrollment (Actual)

32

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asian

Description

Inclusion Criteria:

  • Eyes with DME (center or non-center involving) with <350 microns central retinal thickness

Exclusion Criteria:

  • Subfoveal exudates, history of VR surgery, history of macular laser

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
two subthreshold parameters
5% and 15% duty cycle (DC)
Procedure: Laser
standard ETDRS
early treatment of diabetic retinopathy study
Procedure: Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA
Time Frame: 3 months
Comparing the number of leaking microaneuyrms baseline to 6 weeks with 3 types of lasers (two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS continuous wave (CW) laser.
3 months

Collaborators and Investigators

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

Sponsor

L.V. Prasad Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 22, 2014

Primary Completion (Actual)

December 22, 2014

Study Completion (Actual)

August 11, 2015

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVPEI-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Diabetic Retinopathy

Clinical Trials on Laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe