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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03571659
Enrollment
32
Registered
2018-06-27
Start date
2014-12-22
Completion date
2015-08-11
Last updated
2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

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

Interventions

PROCEDURELaser

Sponsors

L.V. Prasad Eye Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
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

Design outcomes

Primary

MeasureTime frameDescription
1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA3 monthsComparing 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026