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

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

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

Study Overview

• Status: Terminated
• Conditions: Cataract; Presbyopia
• Intervention / Treatment: Device: LensAR Laser System

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Makati City, Philippines, 1200
    • Asian Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increased objective amplitude of accommodation	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of adverse events	1 month

Collaborators and Investigators

• Sponsor: LensAR Incorporated
• Investigators: Principal Investigator: Harvey S Uy, MD, Asian Eye Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): October 4, 2011
• Study Completion (Actual): October 4, 2011

Study Registration Dates

• First Submitted: February 3, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Presbyopia; Accommodation; Crystalline lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: 52-00013-000 Rev C