Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

Innovative Medical

Status and phase: Completed; Phase 4

Conditions: Cataracts

Treatments: Procedure: Femtosecond Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01383057

FEMTO 2011-2

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: 29 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 Mentor Potential Acuity Meter (PAM) laser interferometer, McIntyre Pinhole, or his/her judgment to estimate the patient's potential acuity.

Exclusion criteria

• Concurrent participation or participation in the last thirty days in any other clinical trial.
• Known steroid IOP responder
• Taking medications that may affect vision, IOP or ease of cataract surgery (e.g., Flomax, Glaucoma mediations, 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 IOP >25 mmHg by tonometry 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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29 participants in 1 patient group

Femtosecond Laser

Experimental group

Treatment:

Procedure: Femtosecond Laser