Evaluating femtosecond laser assisted cataract and lens surgery
| ISRCTN | ISRCTN49681405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49681405 |
| Secondary identifying numbers | Protocol version 4.3 |
- Submission date
- 21/08/2012
- Registration date
- 30/08/2012
- Last edited
- 07/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
In femtosecond laser-assisted surgery a laser is used to create tiny incisions in the eye through which the old cloudy lens or cataract is removed and the new lens is implanted. The system has recently been introduced into the European Union and clinical use is limited, so we are evaluating the use of this system.
Who can participate?
Adults (aged over 16) undergoing refractive lens or cataract surgery.
What does the study involve?
Data on the results of your surgery will be analysed. We will also carry out some additional tests before and after surgery to determine the health of your eyes.
What are the possible benefits and risks of participating?
The additional tests are all non-contact, non-invasive and involve no discomfort. It is likely to take a maximum of 1 hour of extra time to perform these. There is no additional charge for you to be part of the study. The measurements performed will be providing additional information about the health of your eyes. However, overall it is unlikely that you will benefit personally from helping with this research project, but the results of the research should be of benefit to the large number of patients in the future.
Where is the study run from?
Moorfields Eye Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2012 to August 2013
Who is funding the study?
Investigator initiated and funded (UK)
Who is the main contact?
Julian Stevens
info@julianstevens.co.uk
Contact information
Scientific
81 Britannia Walk
London
N1 7RH
United Kingdom
| Phone | +44 20 7251 4835/4836 |
|---|---|
| info@julianstevens.co.uk |
Study information
| Study design | Prospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non 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 | Prospective observational study to evaluate femtosecond laser lens fragmentation, anterior capsulotomy cataract and lens extraction surgery |
| Study objectives | To describe the safety of femtosecond laser lens fragmentation and anterior capsulotomy assisted cataract and lens surgery |
| Ethics approval(s) | NRES Committee London - City Road & Hampstead, 30/01/2012, ref: 12/LO/0042 |
| Health condition(s) or problem(s) studied | Cataract, refractive error |
| Intervention | This is an observational study of surgery outcomes. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | To record any complications or adverse events |
| Secondary outcome measures | To describe the ability of the intraocular femtosecond laser to successfully perform an anterior capsulotomy and phakofragmentation during cataract/lens surgery. |
| Overall study start date | 28/08/2012 |
| Completion date | 28/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Any subject planned to undergo femtosecond laser assisted lens surgery. These subjects will already meet these criteria: 1. Subjects must be adults (>16 years), undergoing refractive lens or cataract surgery 2. Subjects must provide informed consent, have signed the written informed consent form, and been given a copy 3. Subjects must have a calculated average corneal power after of ≤ 50.00 D in the eye to be implanted 4. Subjects must have a pharmacologically dilated pupil >6.0 mm, in the eye to be implanted 5. The central anterior chamber depth must be >2.0 mm (Pentacam) 6. Subjects must be willing and able to return for scheduled follow up examinations for 3 months after surgery |
| Key exclusion criteria | 1. Subjects with subluxated crystalline lens 2. Subjects with endothelial dystrophy, guttata, in the eye to be implanted 3. Subjects with keratoconus (or keratoconus suspect) in the eye to be implanted or K>50 D 4. Subjects with distorted or unclear corneal mires on topography maps of the eye to be implanted 5. Subjects with a history of Herpes zoster or Herpes simplex keratitis. 6. The central anterior chamber depth <2.0 mm (Pentacam) 7. Tremor with head titubation 8. Subjects who are participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation |
| Date of first enrolment | 28/08/2012 |
| Date of final enrolment | 28/08/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
N1 7RH
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Sue Lydeard
Research & Development
162 City Road
London
EC1V 2PD
England
United Kingdom
| Website | http://www.moorfields.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03tb37539 |
Funders
Funder type
Other
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
07/12/2017: No publications found in PubMed, verifying study status with principal investigator.
