This trial is active, not recruiting.

Condition cataract
Treatments lensar laser system, conventional phacoemulsification
Phase phase 2/phase 3
Sponsor LensAR Incorporated
Start date November 2009
End date June 2011
Trial size 100 participants
Trial identifier NCT01014702, 52-00006-000


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
lensar laser system
Use of laser for capsulotomy and lens fragmentation
(Active Comparator)
conventional phacoemulsification
Use of standard techniques for capsulotomy and lens fragmentation

Primary Outcomes

Completeness and ease of opening of capsulotomy
time frame: Day 0 (Surgery)
Reduced need for ultrasound phacoemulsification compared to control eye
time frame: Day 0 (surgery)
Rate of adverse events
time frame: 3 months

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

Official title Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by LensAR Incorporated.