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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- L.V. Prasad Eye Institute
- Enrollment
- 32
- Primary Endpoint
- 1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Jay Chhablani
Principal Investigator
L.V. Prasad Eye Institute