Evaluation of cataract surgery and lens implantation in diabetics
| ISRCTN | ISRCTN93583656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93583656 |
| Secondary identifying numbers | 09/H0402/107 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Comparison of glistenings in two hydrophobic acrylic intraocular lenses after cataract surgery in diabetics: a randomised controlled trial |
| Study hypothesis | 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 |
| Condition | 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 | 1. Glistenings 2. Vision Taken at 1, 3, 6, 12, 24 and 36 months. |
| Secondary outcome measures | 1. Post-operative inflammation after cataract surgery and cellular deposition on the IOL surface 2. Objective optical quality and wave-front aberration 3. Contrast sensitivity 4. Diabetic retinopathy after cataract surgery Taken at 1, 3, 6, 12, 24 and 36 months. |
| Overall study start date | 01/01/2010 |
| Overall study end date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | 1. Bilateral cataracts requiring surgery 2. Diabetic 3. Aged 18 years or over, either sex |
| Participant exclusion criteria | Diabetic maculopathy |
| Recruitment start date | 01/01/2010 |
| Recruitment end date | 01/01/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guys and St Thomas' Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Karen Ignatian
London
SE1 7EH
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Charity
Fight for Sight (UK)
Government organisation / Trusts, charities, foundations (both public and private)
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Fight for Sight, Inc., National Council to Combat Blindness, Fight for Sight (U.S.), FFS
- Location
- United States of America
Advanced Vision Science (AVS) (UK) - providing intraocular lenses
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/10/2017: No publications found, verifying study status with principal investigator.
