Prospective Clinical Trial of the LensAR Laser System
This trial is active, not recruiting.
|Treatments||lensar laser system, conventional phacoemulsification|
|Phase||phase 2/phase 3|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
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.
|Official title||Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity|
Call for more information