Evaluation of cataract surgery and lens implantation in diabetics
| ISRCTN | ISRCTN93583656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93583656 |
| Protocol serial number | 09/H0402/107 |
| Sponsor | Guys and St Thomas' Hospital NHS Foundation Trust (UK) |
| Funders | Fight for Sight (UK), Advanced Vision Science (AVS) (UK) - providing intraocular lenses |
- Submission date
- 30/10/2009
- Registration date
- 15/12/2009
- Last edited
- 02/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
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 David Spalton
Scientific
Scientific
Ophthalmology Department
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
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 | Comparison of glistenings in two hydrophobic acrylic intraocular lenses after cataract surgery in diabetics: a randomised controlled trial |
| Study objectives | Hydrophobic acrylic intraocular lenses (IOL) account for the majority of the market in the UK. In some patients microvacuoles known as glistenings are seen to form in the IOL material in the first 2 years after surgery. These do not affect visual acuity after surgery, but could cause light scatter in the eye and glare. They are seen more commonly clinically in eyes with damaged blood aqueous barriers, such as in diabetes or uveitis. Recently a new intraocular lens (AVS) which has a slightly higher water content (4% versus less than 1%) does not appear to develop glistenings. The aim of this study is to compare this IOL with a standard hydrophobic IOL in diabetic patients. |
| Ethics approval(s) | St Thomas' Research Ethics Committee, 27/10/2009 |
| Health condition(s) or problem(s) studied | Cataract |
| Intervention | AVS hydrophobic intraocular lens versus AcrySof® intraocular lens. Patients will be randomised to have routine cataract surgery to one eye with implantation of either the Santen or the AcrySof® lens. Randomisation will be via a remote computer based website. Surgery to the second eye will be performed within 6 weeks of the first operation by the same surgeon, with the other intraocular lens type. Patients will be followed up for a total of 3 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Glistenings |
| Key secondary outcome measure(s) |
1. Post-operative inflammation after cataract surgery and cellular deposition on the IOL surface |
| Completion date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Bilateral cataracts requiring surgery 2. Diabetic 3. Aged 18 years or over, either sex |
| Key exclusion criteria | Diabetic maculopathy |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 01/01/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
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
02/10/2017: No publications found, verifying study status with principal investigator.
