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CompletedNCT03571659Updated Jun 27, 2018

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

An observational study in Diabetic Retinopathy, sponsored by L.V. Prasad Eye Institute. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-06-27.

Sponsored by L.V. Prasad Eye Institute · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
32
Ages
18 Years to 99 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Diabetic Retinopathy
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 32 is below the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

L.V. Prasad Eye Institute is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Asian

Inclusion criteria

  • Eyes with DME (center or non-center involving) with \<350 microns central retinal thickness

Exclusion criteria

Exclusion Criteria:

  • Subfoveal exudates, history of VR surgery, history of macular laser
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • two subthreshold parameters

    5% and 15% duty cycle (DC)

    Procedure: Laser

  • standard ETDRS

    early treatment of diabetic retinopathy study

    Procedure: Laser

Interventions

  • ProcedureLaser
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Chhablani J, Alshareef R, Kim DT, Narayanan R, Goud A, Mathai A. Comparison of different settings for yellow subthreshold laser treatment in diabetic macular edema. BMC Ophthalmol. 2018 Jul 11;18(1):168. doi: 10.1186/s12886-018-0841-z. PubMed 29996798 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03571659
Lead sponsor
L.V. Prasad Eye Institute
Responsible party
Dr Jay Chhablani (Principal Investigator, L.V. Prasad Eye Institute) — Principal investigator
First posted
Jun 27, 2018
Start date
Dec 22, 2014
Primary completion
Dec 22, 2014
Completion
Aug 11, 2015
Last update
Jun 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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