Prospective Clinical Trial of the LensAR Laser System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by LensAR Incorporated.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
LensAR Incorporated
ClinicalTrials.gov Identifier:
NCT01014702
First received: November 13, 2009
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Cataract
Device: LensAR Laser System
Device: Conventional phacoemulsification
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by LensAR Incorporated:

Primary Outcome Measures:
  • Completeness and ease of opening of capsulotomy [ Time Frame: Day 0 (Surgery) ] [ Designated as safety issue: No ]
  • Reduced need for ultrasound phacoemulsification compared to control eye [ Time Frame: Day 0 (surgery) ] [ Designated as safety issue: No ]
  • Rate of adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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 ClinicalTrials.gov identifier: NCT01014702

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

No publications provided

Responsible Party: Keith Edwards, Director Clinical & Regulatory Affairs, LensAR Incorporated
ClinicalTrials.gov Identifier: NCT01014702     History of Changes
Other Study ID Numbers: 52-00006-000
Study First Received: November 13, 2009
Last Updated: April 14, 2011
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by LensAR Incorporated:
Cataract
Capsulotomy
Capsulorrhexis
lens fragmentation
phacoemulsification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014