Feasibility Study of Laser Treatment of the Crystalline Lens to Correct Presbyopia

NCT ID: NCT01062412

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-10-04

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

Conditions

Presbyopia; Cataract

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

LensAR Laser System

Laser treatment of the crystalline lens

Intervention Type: DEVICE

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 2.
• 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.
• Subjects using systemic medication that is known to reduce the amplitude of accommodation (such as medication for motion sickness containing hyoscine or other antimuscarinic drugs, anticholinergic drugs, anti-psychotic drugs, tricyclic antidepressants and other drugs acting on the central nervous system).
• Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LensAR Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harvey S Uy, MD

Role: PRINCIPAL_INVESTIGATOR

Asian Eye Institute

Locations

Asian Eye Institute

Makati City, , Philippines

Countries

Philippines

Other Identifiers

52-00013-000 Rev C

Identifier Type: -

Identifier Source: org_study_id