Near-Infrared Light Photobiomodulation Treatment for Retinal Vein Occlusion Macular Oedema
Australia14 participantsStarted 2021-01-01
Plain-language summary
This pilot study aims to establish that treatment with near infrared light (NIR) reduces cystic macular oedema in patients with a retinal vein occlusion.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
* …
What they're measuring
1
Reduction in central macular thickness (CMT) measured by optical coherence tomography (OCT) 12 weeks from baseline, in participants with macular edema from a retinal vein occlusion (RVO)