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

This study has been completed.
Information provided by (Responsible Party):
Innovative Medical Identifier:
First received: June 24, 2011
Last updated: February 15, 2012
Last verified: February 2012
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
Procedure: Femtosecond Laser
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

Resource links provided by NLM:

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: 3 months ]
    Measure the fluid pressure inside the eye

  • 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).

Enrollment: 29
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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
  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 identifier: NCT01383057

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

Responsible Party: Innovative Medical Identifier: NCT01383057     History of Changes
Other Study ID Numbers: FEMTO 2011-2
Study First Received: June 24, 2011
Last Updated: February 15, 2012

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases processed this record on May 25, 2017