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

June 24, 2011
February 15, 2012
June 2011
February 2012   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01383057 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cataracts
Procedure: Femtosecond Laser
Using the Femtosecond Laser to make a clear corneal incision.
Experimental: Femtosecond Laser
Intervention: Procedure: Femtosecond Laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01383057
FEMTO 2011-2
No
Innovative Medical
Innovative Medical
Not Provided
Not Provided
Innovative Medical
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP