Trials / Completed
CompletedNCT03866473
A Pilot Study Evaluating Photobiomodulation Therapy for Diabetic Macular Edema
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- Jaeb Center for Health Research · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study is being conducted to assess the effects of photobiomodulation on CST compared with sham in eyes with central-involved DME and good vision. Photobiomodulation is irradiation by light in the 630-900 nanometer region of the spectrum. Furthermore, this pilot study is being conducted to determine whether the conduct of a pivotal trial has merit based on an anatomic outcome and provide information on outcome measures needed to design a pivotal trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Retilux | 670nm wavelength light |
| DEVICE | Sham Light Device | Broad spectrum light device |
Timeline
- Start date
- 2019-04-10
- Primary completion
- 2020-09-04
- Completion
- 2020-11-13
- First posted
- 2019-03-07
- Last updated
- 2022-09-19
- Results posted
- 2022-06-10
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03866473. Inclusion in this directory is not an endorsement.