Condition category
Eye Diseases
Date applied
21/08/2012
Date assigned
30/08/2012
Last edited
27/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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(0)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 measures

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

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

http://www.moorfields.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes