Prospective Clinical Trial of the LensAR Laser System

NCT ID: NCT01014702

Last Updated: 2011-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser Treatment

Group Type EXPERIMENTAL

LensAR Laser System

Intervention Type DEVICE

Use of laser for capsulotomy and lens fragmentation

Phacoemulsifcation

Group Type ACTIVE_COMPARATOR

Conventional phacoemulsification

Intervention Type DEVICE

Use of standard techniques for capsulotomy and lens fragmentation

Interventions

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LensAR Laser System

Use of laser for capsulotomy and lens fragmentation

Intervention Type DEVICE

Conventional phacoemulsification

Use of standard techniques for capsulotomy and lens fragmentation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LensAR Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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LensAR Incorporated

Locations

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Asociacion para Evitar la Ceguera en Mexico IAP

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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52-00006-000

Identifier Type: -

Identifier Source: org_study_id

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