A Single Center, Prospective Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens to Correct Presbyopia: Philippines

LensAR Incorporated1 site in 1 country80 target enrollmentDecember 2009

ConditionsPresbyopia Cataract

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Presbyopia
Sponsor: LensAR Incorporated
Enrollment: 80
Locations: 1
Primary Endpoint: Increased objective amplitude of accommodation
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study will evaluate whether the LensAR laser system can be used in the lens of the eye to increase the ability to read and/or see near objects

Detailed Description

The objective of this study is to evaluate the feasibility of the LensAR Laser System to surgically intervene within the crystalline lens to improve vision by increasing amplitude of accommodation in patients having elected to undergo lens extraction and IOL implantation

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

October 4, 2011

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

LensAR Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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 to treat their ocular disorder then elect to have the LensAR laser surgery as part of the procedure.
•Cataract should not exceed LOCS III Grade
•Subjects must have best corrected distance visual acuity of 20/40 or better in the eye to be treated .
•Subjects must be ≥ 45 years and ≤ 60 years of age at time of subject eligibility visit.
•Subjects must be willing and able to return for scheduled follow up examinations for 6 months after cataract surgery or up to 3 years (at 6 month intervals) if no cataract surgery is performed.
•Subject must have central 7 mm of clear cornea without vascularization

Exclusion Criteria

•Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
•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.
•Subjects who cannot attain ocular dilation adequate to allow laser treatment within the minimum range based on the laser procedure to be applied.
•Subjects with known sensitivity to planned study concomitant medications.