Evaluating femtosecond laser assisted cataract and lens surgery

• Register: ISRCTN
• Last refreshed on: 8 January 2018
• Main ID: ISRCTN49681405
• Date of registration: 30/08/2012
• Prospective Registration: No
• Primary sponsor: Moorfields Eye Hospital (UK)
• Public title: Evaluating femtosecond laser assisted cataract and lens surgery
• Scientific title: Prospective observational study to evaluate femtosecond laser lens fragmentation, anterior capsulotomy cataract and lens extraction surgery
• Date of first enrolment: 28/08/2012
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN49681405
• Study type: Observational
• Study design: Prospective observational study (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Julian Stevens

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cataract, refractive error
Eye Diseases
Other cataract

Intervention(s)

This is an observational study of surgery outcomes.

Primary Outcome(s)

To record any complications or adverse events

Secondary Outcome(s)

To describe the ability of the intraocular femtosecond laser to successfully perform an anterior
capsulotomy and phakofragmentation during cataract/lens surgery.

Secondary ID(s)

Protocol version 4.3

Source(s) of Monetary Support

Investigator initiated and funded