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

• Sponsor: Innovative Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01383057
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 3.6

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
• Actual Enrollment: 29 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

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 [3 months]

   Measure the fluid pressure inside the eye

2. Uncorrected and Best corrected Visual Acuity [one 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 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Innovative Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovative Medical
• ClinicalTrials.gov Identifier: NCT01383057
• Other Study ID Numbers: FEMTO 2011-2
• First Posted: Jun 28, 2011
• Last Update Posted: Feb 17, 2012
• Last Verified: Feb 1, 2012

• Additional relevant MeSH terms: Cataract; Surgical Wound

Study Results

No Results Posted as of Feb 17, 2012