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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014