Prospective Clinical Trial of the LensAR Laser System

Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity

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.

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Device: LensAR Laser System; Device: Conventional phacoemulsification

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Asociación para Evitar la Ceguera en Mexico IAP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LensAR Incorporated

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: November 13, 2009
• First Submitted That Met QC Criteria: November 16, 2009
• First Posted (Estimate): November 17, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2011
• Last Update Submitted That Met QC Criteria: April 14, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: phacoemulsification; Cataract; Capsulotomy; Capsulorrhexis; lens fragmentation
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 52-00006-000