Prospective Clinical Trial of the LensAR Laser System

Sponsor

LensAR Incorporated (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01014702

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Jun 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.