ISRCTN47403123Terminated未知
Efficacy of the Telescopic Mirror Implant for Age-related Macular Degeneration: The MIRROR Trial
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Terminated
- Enrollment
- 132
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
Similar Trials
Completed
Phase 2
The effect of mirror therapy on rehabilitation of stroke patientsstroke.Cerebrovascular disease, unspecifiedIRCT201204289575N1Vice Chancellor for Research, Mashhad University of Medical Sciences40
Completed
Phase 2
effectiveness of Mirror Visual Feedback on sensory relearning outcomesCondition 1: Injury of median nerve at wrist of upper extrimity. Condition 2: Injury of ulnar nerve at wrist of upper extrimity.other lesions of median nervelesions of ulnar nerveIRCT20150721023277N5Vice chancellor for research, Iran University of Medical Sciences20
Not yet recruiting
Not Applicable
Efficiency of mirror therapy (visualising the intact leg via mirror) in prevention of pain developed after removal of the leg by surgeryCTRI/2020/07/026488JIPMER
Completed
Not Applicable
Effectiveness of a robot-assisted mirror therapy with the GlorehaArm paresisI61I63S06Intracerebral haemorrhageIntracranial injuryCerebral infarctionDRKS00015893P.A.N. Zentrum im Fürst Donnersmarck-Haus29
Completed
Not Applicable
Mirror therapy using virtual reality based wearable reflection device for upper extremity rehabilitation in stroke patientsKCT0003047Sahmyook University42