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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LASER

Procedure

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

L.V. Prasad Eye Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2015
First posted: Jun 27, 2018
Registry last updated: Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed