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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01383057
First received: June 24, 2011
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Cataracts
Procedure: Femtosecond Laser
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measure the fluid pressure inside the eye

  • Uncorrected and Best corrected Visual Acuity [ Time Frame: one month ] [ Designated as safety issue: No ]
    Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).


Enrollment: 29
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Femtosecond Laser Procedure: Femtosecond Laser
Using the Femtosecond Laser to make a clear corneal incision.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01383057

Locations
United States, Tennessee
Loden Vision Centers
Goodlettsville, Tennessee, United States
Sponsors and Collaborators
Innovative Medical
  More Information

No publications provided

Responsible Party: Innovative Medical
ClinicalTrials.gov Identifier: NCT01383057     History of Changes
Other Study ID Numbers: FEMTO 2011-2
Study First Received: June 24, 2011
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014