Trials / Completed
CompletedNCT02181400
Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema
Pilot Study of Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- University of Sydney · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This pilot study aims to establish that treatment with near infrared light (NIR) reduces diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive beneficial effect at retinal cellular level.
Detailed description
This pilot study aims to establish that treatment with near infrared light (NIR) reduces diabetic macular oedema in patients suffering diabetic retinopathy by exerting a positive beneficial effect at retinal cellular level. Diabetic retinopathy is a common cause of severe loss of vision and the most common cause of blindness in individuals between the ages of 20 and 65 years in developed countries.Swelling of the central retina or "macular oedema". Patients will be treated in an office clinic,three times a week for a treatment duration of 2 minutes per session, a total of 12 times over the duration of 4 weeks and will be assessed at 8 weeks to establish any change induced in retinal oedema. Safety follow up will be assessed at 3 and 6 months post treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ellex Integre NIR laser | Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate. The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period. |
Timeline
- Start date
- 2016-04-19
- Primary completion
- 2019-02-15
- Completion
- 2019-02-15
- First posted
- 2014-07-03
- Last updated
- 2020-02-07
- Results posted
- 2019-12-23
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT02181400. Inclusion in this directory is not an endorsement.