NCT03571659

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

Same day

First QC Date

May 18, 2018

Last Update Submit

June 18, 2018

Conditions

Diabetic Retinopathy

Outcome Measures

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.

    3 months

Study Arms (2)

two subthreshold parameters

5% and 15% duty cycle (DC)

Procedure: Laser

standard ETDRS

early treatment of diabetic retinopathy study

Procedure: Laser

Interventions

LaserPROCEDURE
standard ETDRStwo subthreshold parameters

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asian

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29996798DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Lasers

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2018

First Posted

June 27, 2018

Study Start

December 22, 2014

Primary Completion

December 22, 2014

Study Completion

August 11, 2015

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share