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

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Procedure: Laser

• Registration Number: NCT03571659
• Lead Sponsor: L.V. Prasad Eye Institute

Brief Summary

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

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 Timeline

• Study Start: 2014-12-22
• Primary Completion: 2014-12-22
• Study Completion: 2015-08-11
• Study First Submitted: 2018-05-18
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Study First Posted: 2018-06-27
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
standard ETDRS	Laser	early treatment of diabetic retinopathy study
two subthreshold parameters	Laser	5% and 15% duty cycle (DC)

Primary Outcome Measures

Name	Time	Method
1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA	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.