Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema (NIRVO)
Macula Edema, Retinal Vein Occlusion
About this trial
This is an interventional treatment trial for Macula Edema
Eligibility Criteria
Inclusion Criteria:
- Diagnosis macular edema secondary to branch or central vein occlusion (BRVO or CRVO)
- CMT of >300 µm and less than 550 µm;
- Best corrected visual acuity of 6/6 to 6/24 (letters 87 - 53);
- Intraocular pressure < 25 mmHg;
- Written informed consent has been obtained.
Exclusion Criteria:
- Loss of vision due to other causes (e.g. age-related macular degeneration, myopic macular degeneration, DME);
- Known allergy to agents used in the study e.g. fluorescein;
- Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using reliable means of contraception;
- Only eye (vision in other eye <6/60);
- Study eye is an amblyopic eye;
- Macular oedema due to other causes;
- Significant diabetic retinopathy;
- An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy or substantial premacular fibrosis;
- Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline.
- Previous use of intraocular or periocular steroids in study eye at any time prior to baseline;
- Cataract surgery within the last 3 months;
- Retinal laser treatment within the last 6 months;
- Media opacity including cataract that already precludes adequate macular photography or cataract that is likely to require surgery within 6 months;
- Intercurrent severe disease such as septicaemia, any condition which would affect follow-up;
- History of chronic renal failure requiring dialysis or renal transplant;
- Blood pressure >180/120;
- Participant has a condition or is in a situation that in the investigator's opinion may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Sites / Locations
- Macular Research Group, Save Sight Institute, The University of SydneyRecruiting
Arms of the Study
Arm 1
Experimental
NIR laser treatment 200mW/cm2 dose
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.