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Laser Cataract Surgery With the Femtosecond Laser Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01382823
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : October 6, 2011
Information provided by:
Innovative Medical

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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

Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: three month ]
    Measure the fluid pressure inside the eye.

  2. Uncorrected and Best corrected Visual Acuity [ Time Frame: three month ]
    Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01382823

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

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Responsible Party: Melissa Earl, CRO Identifier: NCT01382823     History of Changes
Other Study ID Numbers: FEMTO 2010
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases