How well does the OriLens (Hubble-type) implant work in improving vision in age-related macular degeneration?

Not Applicable

• Conditions: Specialty: Ophthalmology, Primary sub-specialty: Retina (including Diabetes); UKCRC code/ Disease: Eye/ Disorders of choroid and retina; Eye Diseases; Age-related Macular Degeneration

• Registration Number: ISRCTN47403123
• Lead Sponsor: Belfast Health & Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-24
• Study Completion: 2019-02-28
• Last Update Posted: 15 March 2021

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BCDVA is measured using number of letters improvement on ETDRS Chart at baseline and 12 months.

Secondary Outcome Measures

Name	Time	Method
<br> 1. BCDVA is measured using number of letters improvement on ETDRS Chart at one, three and six months<br> 2. BCNVA, reading speed and contrast sensitivity is measured by MNRead Chart and MARS Chart at baseline and 12 months<br> 3. Vision-specific quality of life measured using the IVI at baseline, six and 12 months<br> 4. Health related quality of life status is measured using the EQ-5D-5L questionnaire at baseline, six and 12 months<br> 5. Health service use and associated costs are measured by a Health Service Use Questionnaire at six and 12 months<br>