Laser Cataract Surgery With the Femtosecond Laser Technology

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01382823
First received: June 24, 2011
Last updated: October 5, 2011
Last verified: October 2011
  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: Laser Cataract Surgery With the Femtosecond Laser Technology

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

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

  • Uncorrected and Best corrected Visual Acuity [ Time Frame: three 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).


Estimated Enrollment: 10
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382823

Locations
United States, Tennessee
Loden Vision Centers
Goodlettsville, Tennessee, United States
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: James Loden, MD Loden Vision Centers
  More Information

No publications provided

Responsible Party: Melissa Earl, CRO
ClinicalTrials.gov Identifier: NCT01382823     History of Changes
Other Study ID Numbers: FEMTO 2010
Study First Received: June 24, 2011
Last Updated: October 5, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014