Laser Cataract Surgery With the Femtosecond Laser Technology

Innovative Medical

Status and phase: Completed; Phase 4

Conditions: Cataracts

Treatments: Procedure: Femtosecond Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01382823

FEMTO 2010

Details and patient eligibility

About

The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.
• Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.
• The surgeon may use the Mento Potential Acuity Meter (PAM)laser interferometer, McIntyre Pinhole, or his/her judgement to estimate the patient's potential acuity.

Exclusion criteria

• Concurrent participation or participation in the last 30 days in other clinical trials.
• Known steroid IOP responder.
• Taking medications that may affect vision, IOP, or ease of cataract surgery (e.g. Flomax, Glaucoma medications, etc.).
• Acute or chronic disease or illness that would increase risk or confound study results(e.g. uncontrolled diabetes mellitus, immunocompromised, etc.).
• Uncontrolled systemic or ocular disease.
• Corneal abnormalities (e.g. stromal, epithelial, or endothelial dystrophies)
• Pseudoexfoliation.
• Ocular hypertension (>or =20hg) or glaucomatous changes in the optic nerve.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Femtosecond Laser

Experimental group

Treatment:

Procedure: Femtosecond Laser