Evaluation of reading vision after cataract surgery and lens implantation
| ISRCTN | ISRCTN44390838 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44390838 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/10/2009
- Registration date
- 26/10/2009
- Last edited
- 04/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr David Spalton
Scientific
Scientific
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 below to request a patient information sheet |
| Scientific title | Comparison of near vision performance of the Crystalens® HD against the Technis® Aspheric Intra-Ocular Lens: a randomised controlled trial |
| Study objectives | The Crystalens® HD is a new accommodative intra-ocular lens (IOL) which may potentially improve reading and near vision compared to standard monofocal lenses. The performance of this IOL will be compared to a standard monofocal IOL. |
| Ethics approval(s) | Guys' Hospital Research Ethics Committee, London, 08/10/2009, ref: 09/H804/82 |
| Health condition(s) or problem(s) studied | Cataracts/near vision/intra-ocular lens |
| Intervention | Crystalens® HD vs standard monofocal IOL Participants and outcome assessors will be blinded to participant allocation. |
| Intervention type | Other |
| Primary outcome measure | Visual acuity All primary and seconadry outcomes will be assessed at 1, 3, 6, 12 and 24 months. |
| Secondary outcome measures | 1. Refraction 2. Objective optical image quality 3. Posterior capsule opacification 4. Measurement of IOL position 5. Contrast sensitivity 6. Objective and subjective measure of accommodation 7. Pupil size All primary and seconadry outcomes will be assessed at 1, 3, 6, 12 and 24 months. |
| Overall study start date | 20/11/2009 |
| Completion date | 20/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 (40 per group) |
| Key inclusion criteria | 1. Both males and females, aged 18 years or older 2. Documented diagnosis of bilateral cataract requiring surgery 3. Potential visual acuity of 6/12 or better in both eyes 4. Patients who require an IOL in the range of 10-30 dioptres 5. Corneal astigmatism less than/equal to 1.0 dioptres after cataract surgery 6. Patients willing and able to provide informed consent and able to attend follow-up appointments |
| Key exclusion criteria | 1. Any coexisting ocular disease 2. Treatment with any ocular medication apart from artificial tear drops 3. Patients who are not fluent in English 4. Females of childbearing potential who are currently pregnant or breastfeeding |
| Date of first enrolment | 20/11/2009 |
| Date of final enrolment | 20/11/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Karen Ignatian
R&D Department
2nd Floor, Conybeare House
Great Maze pond
London
SE1 9RT
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Government
Guy's and St Thomas' NHS Foundation Trust (UK) - Cataract and IOL Research Fund
No information available
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
Bausch and Lomb (USA) - providing the 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2013 | Yes | No |
