Prospective Clinical Trial of the LensAR Laser System

Phase 2

• Conditions: Cataract
• Interventions: Device: LensAR Laser System; Device: Conventional phacoemulsification

• Registration Number: NCT01014702
• Lead Sponsor: LensAR Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-14
• Last Update Posted: 2011-04-15
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Treatment	LensAR Laser System	-
Phacoemulsifcation	Conventional phacoemulsification	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asociacion para Evitar la Ceguera en Mexico IAP; 🇲🇽 Mexico City, Mexico