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A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema

NCT03866473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2022-09-19

Study results available
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Summary

Randomized clinical trial evaluating the effect of photobiomodulation compared with sham on central subfield thickness (CST) in eyes with central-involved DME and good vision.

Conditions

Interventions

DEVICE

Retilux

670nm wavelength light

DEVICE

Sham Light Device

Broad spectrum light device

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Eye Institute (NEI)

    collaborator NIH

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • PhotoOptx LLC

    collaborator INDUSTRY

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Judy Kim, MD · Medical College of Wisconsin Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2020-09-04
Completion
2020-11-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866473 on ClinicalTrials.gov