CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Ellex Integre NIR laserdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02181400
NCT02181400N/ACompleted
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Pilot Study of Near Infrared Photobiomodulation Treatment for Diabetic Macular Oedema

University of Sydney·interventional·Posted Jul 3, 2014·Updated Feb 7, 2020

In Brief

A clinical study evaluating Ellex Integre NIR laser for Diabetic Macular Oedema. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Oedema
CountriesAustralia
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 3, 2014
Enrollment StartApr 19, 2016
Primary CompletionFeb 15, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.0 years ago

Interventions

Ellex Integre NIR laserdevice

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.