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

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ClinicalTrials.gov Identifier: NCT01383057
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
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

Study Type : Interventional  (Clinical Trial)
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 : June 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

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: 3 months ]
    Measure the fluid pressure inside the eye

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT01383057


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

Responsible Party: Innovative Medical
ClinicalTrials.gov Identifier: NCT01383057     History of Changes
Other Study ID Numbers: FEMTO 2011-2
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Cataract
Surgical Wound
Lens Diseases
Eye Diseases
Wounds and Injuries