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

Primary Purpose

Presbyopia, Cataract

Status
Terminated
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
LensAR Laser System
Sponsored by
LensAR Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia focused on measuring Accommodation, Presbyopia, Crystalline lens

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesAccepts 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 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.

Sites / Locations

  • Asian Eye Institute

Outcomes

Primary Outcome Measures

Increased objective amplitude of accommodation

Secondary Outcome Measures

Rate of adverse events

Full Information

First Posted
February 3, 2010
Last Updated
March 7, 2022
Sponsor
LensAR Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01062412
Brief Title
Feasibility Study of Laser Treatment of the Crystalline Lens to Correct Presbyopia
Official Title
A Single Center, Prospective Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens to Correct Presbyopia: Philippines
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
No improvement in near vision was detected
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 4, 2011 (Actual)
Study Completion Date
October 4, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LensAR Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Cataract
Keywords
Accommodation, Presbyopia, Crystalline lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
LensAR Laser System
Intervention Description
Laser treatment of the crystalline lens
Primary Outcome Measure Information:
Title
Increased objective amplitude of accommodation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Rate of adverse events
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey S Uy, MD
Organizational Affiliation
Asian Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asian Eye Institute
City
Makati City
ZIP/Postal Code
1200
Country
Philippines

12. IPD Sharing Statement

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

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