Laser Cataract Surgery With the Femtosecond Laser Technology

• Sponsor: Innovative Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01382823
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Procedure: Femtosecond Laser	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Laser Cataract Surgery With the Femtosecond Laser Technology
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Femtosecond Laser	Procedure: Femtosecond Laser; Using the Femtosecond Laser to make a clear corneal incision.

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure [three month]

   Measure the fluid pressure inside the eye.

2. Uncorrected and Best corrected Visual Acuity [three month]

   Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loden Vision Centers	Goodlettsville	Tennessee	United States

Sponsors and Collaborators

• Innovative Medical

Investigators

• Principal Investigator: James Loden, MD, Loden Vision Centers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01382823
• Other Study ID Numbers: FEMTO 2010
• First Posted: Jun 27, 2011
• Last Update Posted: Oct 6, 2011
• Last Verified: Oct 1, 2011

• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Oct 6, 2011