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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01014702

Enrollment

100

Registered

2009-11-17

Start date

2009-11-30

Completion date

2011-06-30

Last updated

2011-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

Cataract, Capsulotomy, Capsulorrhexis, lens fragmentation, phacoemulsification

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.

Interventions

DEVICELensAR Laser System

Use of laser for capsulotomy and lens fragmentation

DEVICEConventional phacoemulsification

Use of standard techniques for capsulotomy and lens fragmentation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026