Prospective randomised trial of the surface cytology of 3 different single piece acrylic intraocular lenses (IOL)
| ISRCTN | ISRCTN64865132 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64865132 |
| Protocol serial number | N0112146488 |
| Sponsor | Department of Health |
| Funder | Epsom and St Helier University Hospitals NHS Trust (UK) NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 09/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Paul G Ursell
Scientific
Scientific
The Roy Harfitt Eye Unit
Sutton Hospital
Cotswold Road
Sutton, Surrey
SM2 5LT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Prospective randomised trial of the surface cytology of 3 different single piece acrylic intraocular lenses (IOL) |
| Study objectives | The aim of this study is to assess the biocompatibility of the most commonly used IOL Acrysof with two new acrylic IOLs recently approved for use in the UK, Centreflex and Akreso-fit. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Eye |
| Intervention | IOL Acrysof vs two new acrylic IOLs recently approved for use in the UK, Centreflex and Akreso-fit |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Understanding the biocompatibility of these IOLs will enable surgeons to ascertain whether these IOLs are safe for use in all cases, and also whether there are any unexpected complications that may arise on extended analysis such as this. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients who are undergoing routine cataract surgery without pre-existing ocular of systemic disease. |
| Key exclusion criteria | Pre-existing ocular or systematic disease which may interfere with their post-operative inflammatory course, including diabetic retinopathy, glaucoma, uveitis, pseudoexfloiation, previous eye surgery, contralateral surgery in the previous 4 months, extremes of age (<60, >90 years), significant macular degeneration or amblyopia precluding a post-operative vision of >6/12, mature cataracts requiring Visual Blue for extraction. |
| Date of first enrolment | 31/10/2002 |
| Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Roy Harfitt Eye Unit
Sutton, Surrey
SM2 5LT
United Kingdom
SM2 5LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/09/2016: No publications found in PubMed, verifying study status with principal investigator.
