Prospective Clinical Trial of the LensAR Laser System

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: NCT01014702
Recruitment Status : Unknown
Verified April 2011 by LensAR Incorporated.
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2009
Last Update Posted : April 15, 2011
Information provided by:
LensAR Incorporated

Brief Summary:
The LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery.

Condition or disease Intervention/treatment Phase
Cataract Device: LensAR Laser System Device: Conventional phacoemulsification Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity
Study Start Date : November 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Laser Treatment Device: LensAR Laser System
Use of laser for capsulotomy and lens fragmentation
Active Comparator: Phacoemulsifcation Device: Conventional phacoemulsification
Use of standard techniques for capsulotomy and lens fragmentation

Primary Outcome Measures :
  1. Completeness and ease of opening of capsulotomy [ Time Frame: Day 0 (Surgery) ]
  2. Reduced need for ultrasound phacoemulsification compared to control eye [ Time Frame: Day 0 (surgery) ]
  3. Rate of adverse events [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must sign and be given a copy of the written informed consent form
  • Subjects must have elected to undergo lens extraction and IOL implantation and then elect to have the LensAR laser surgery as part of the procedure.
  • Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
  • Subjects must have central 7 mm of clear cornea without vascularization.

Exclusion Criteria:

  • Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
  • Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
  • Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
  • Subjects with macular degenerative pathology.
  • Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
  • Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
  • Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.

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): NCT01014702

Asociacion para Evitar la Ceguera en Mexico IAP
Mexico City, Mexico
Sponsors and Collaborators
LensAR Incorporated

Responsible Party: Keith Edwards, Director Clinical & Regulatory Affairs, LensAR Incorporated Identifier: NCT01014702     History of Changes
Other Study ID Numbers: 52-00006-000
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Keywords provided by LensAR Incorporated:
lens fragmentation

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases