Cataract, refractive error Eye Diseases Other cataract
Conditions
Interventions
Sponsors
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To record any complications or adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the ability of the intraocular femtosecond laser to successfully perform an anterior capsulotomy and phakofragmentation during cataract/lens surgery. | — |
Countries
United Kingdom