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This pilot study aims to establish that treatment with near infrared light (NIR) reduces cystic macular oedema in patients with a retinal vein occlusion.
Intraocular injections of Vascular Endothelial Growth Factor (VEGF) inhibitors have been shown to improve swelling of central retina (macular oedema) and vision in patients with retinal vein occlusions (RVO), however this treatment comes with potentially sight threatening risks. A less invasive treatment might have many advantages. We recently showed that eyes with macular oedema caused by diabetes, the other main cause of macular oedema, who received treatment with near-infrared (NIR) light was not only safe but was also effective in reducing the swelling. The US Diabetic Retinopathy Research Collaboration are currently recruiting for a larger study of NIR light which may or may not confirm our findings. We propose to test the safety and efficacy of the same NIR light in patients with macular oedema from retinal vein occlusions. We anticipate this may reduce the need for injections of VEGF inhibitors in eyes with RVO, in particular eyes with good vision. This pilot study will help determine whether PBM with NIR for RVO warrants further investigation in a larger study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIR laser treatment 200mW/cm2 dose | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ellex Integre NIR laser | Device | The Ellex Integre NIR (near Infrared Light) Laser dose of 200 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in CMT measured by OCT at 5 and 12 weeks from baseline | 5 & 12 weeks | |
| Mean change in vision from baseline | 12 weeks | |
| Percentage of eyes with no central macular edema at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Cornish, MBBS PhD | Contact | 92837111 | elisa.cornish@sydney.edu.au | |
| Thomas Groeneveld | Contact | 0412338075 | thomas.groeneveld@sydney.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Elisa E Cornish, MBBS PhD | University of Sydney | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macular Research Group, Save Sight Institute, The University of Sydney | Recruiting | Sydney | New South Wales | 2000 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36912792 | Derived | Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14. |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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7 eyes with branch retinal vein occlusion, 7 with central retinal vein occlusion
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| 12 weeks |
| Percentage of eyes that require rescue treatment | Rescue treatment - intravitreal anti-VEGF | baseline to 12 weeks |
| Mean time to rescue treatment | Upto 12 weeks |
| If rescue treatment required, mean time till next anti-VEGF using prn regimen review | 6 months |
| Mean time to oedema recurrence (defined as needing intravitreal treatment) if macular edema resolves | 6 months |
| Changes to deep vascular OCT-Angiography | 12 weeks |
| Fundus Fluorescein Angiography assessment of leak and capillary closure before (at baseline) and at 12 weeks post baseline after intervention | 12 weeks |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |