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NCT03571659 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03571659
Other study ID # LVPEI-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 22, 2014
Est. completion date August 11, 2015

Study information
Verified date June 2018
Source L.V. Prasad Eye Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date August 11, 2015
Est. primary completion date December 22, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Laser

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
L.V. Prasad Eye Institute

Outcome
Type Measure Description Time frame Safety issue
Primary 1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA 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
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