Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mr Julian Stevens
ORCID ID
Contact details
81 Britannia Walk
London
N1 7RH
United Kingdom
+44 20 7251 4835/4836
info@julianstevens.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol version 4.3
Study information
Scientific title
Prospective observational study to evaluate femtosecond laser lens fragmentation, anterior capsulotomy cataract and lens extraction surgery
Acronym
Study hypothesis
To describe the safety of femtosecond laser lens fragmentation and anterior capsulotomy assisted cataract and lens surgery
Ethics approval
NRES Committee London - City Road & Hampstead, 30/01/2012, ref: 12/LO/0042
Study design
Prospective observational study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cataract, refractive error
Intervention
This is an observational study of surgery outcomes.
Intervention type
Procedure/Surgery
Phase
Drug names
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 trial start date
28/08/2012
Overall trial end date
28/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
28/08/2012
Recruitment end date
28/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
81 Britannia Walk
London
N1 7RH
United Kingdom
Sponsor information
Organisation
Moorfields Eye Hospital (UK)
Sponsor details
c/o Sue Lydeard
Research & Development
162 City Road
London
EC1V 2PD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list