Efficacy of the Telescopic Mirror Implant for Age-related Macular Degeneration: The MIRROR Trial

Belfast Health & Social Care Trust0 个研究点目标入组 132 人开始时间: 2017年7月24日最近更新: 2021年3月15日

适应症

试验速览

暂无简介。

•1. Aged between 55 and 100 years (both male and female)
•2. Bilateral stable advanced AMD either neovascular (required to be stable for at least 12 months after last treatment) or atrophic AMD
•3. Bilateral uncomplicated cataract surgery with unifocal intraocular lens positioned within the capsular bag
•4. Bilateral best-corrected distance visual acuity of 6/38-6/240 (LogMAR 0.80 to 1.60)
•5. Must demonstrate a 10-letter improvement in BCDVA (ETDRS chart) with the external x2.5 telescope in the eye for implantation
•6. Must have had experience of using low vision aids
•7. Must have an anterior chamber depth (ACD) of =3mm in both eyes
•8. Must have a pupil size =3mm in diameter in both eyes
•9. Must have an endothelial cell density within normal limits for age (see appendix 1)
•10. Must be willing to undergo laser capsulotomy in the eligible eye prior to randomisation (if not already done)
•11. Must be three months or more following any intraocular surgical procedure and one month following YAG capsulotomy
•12. Must be in good general health with every likelihood of involvement in the trial for the duration of the study and be able to physically or verbally complete the questionnaires

•1. Cataract surgery with multifocal intraocular lenses
•2. A history of glaucoma or of being on anti-glaucomatous medication
•3. Any other retinal condition
•4. Lack of clear view of the retina
•5. Abnormal or de-centred pupil
•6. Endothelial cell density <1500 cells/mm2
•7. History of ocular inflammatory disease
•8. Zonular instability or instability of existing intraocular lens
•9. BCDVA of better than 6/38 (0.80 LogMAR) or worse than 6/240 (1.60 LogMAR) in either eye
•10. Participants unable to provide informed consent
•11. Be in poor general health that could compromise attending follow-up assessments
•12. Difficulties with balance
•13. Not fluent in English

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