ACTRN12612000704897
Completed
未知
A multi-centre, randomised trial into the safety and efficacy of nanosecond microsurgical laser intervention in early age-related macular degeneration.
Overview
- Phase
- 未知
- Status
- Completed
- Enrollment
- 360
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 50 Years to 95 Years (—)
- Sex
- All
Inclusion Criteria
- •Age 50 years and older, and less than 95 years. Best Corrected Visual Acuity (BCVA) of 6/12 (20/40\) or better in each eye. Bilateral high\-risk early AMD (AREDS Simplified Severity Scale, at least 2 risk factors) within an inner macular zone (a circle with a radius of 1500 microns centered on the fovea). A threshold sensitivity less than 25 dB at any point, within a customised grid, as measured using a Macular Integrity Assessment (MAIA) device, at the same location of the one eye on two separate occasions. Pupil dilation of 5mm or more in each eye. Fundus photographs, OCT and FAF images of adequate quality as assessed by the LEAD Image Reading Centre. Ability and willingness to consent, and be randomised, to 2RT or sham laser treatment, and all qualification and follow\-up phases of the study.
Exclusion Criteria
- •Any imaged retinal sign suggestive of geographic atrophy within the macula (a circle with a radius of 3000 microns centred on the fovea). Peri\-papillary atrophy further than 1500 microns from the fovea is allowed.
- •CNV, or past treatment for CNV, in either eye.
- •Any other experimental treatment for AMD, excluding dietary supplements, received in the past 12 months or thought likely to chronically change the course of the participant’s retinal disease.
- •Any OCT image showing evidence of intraretinal fluid (cysts), or subretinal fluid for which CNV cannot be excluded as a cause.
- •A subfoveal pigment epithelial detachment/drusenoid detachment greater than 1000 microns in diameter in either eye.
- •Ocular disease in either eye, other than AMD, which may significantly compromise assessment of the retina, including;
- •Known hypersensitivity to fluorescein.
- •Previous retinal or ocular surgery, the effects of which may now or in the future complicate assessment of the progression of AMD.
- •Requirement for any systemic or ocular medication known to be toxic to the retina.
- •Sensitivity to the application of a contact lens.
Investigators
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