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
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Accommodation, Presbyopia, Crystalline lens
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.
Sites / Locations
- Asian Eye Institute
Outcomes
Primary Outcome Measures
Increased objective amplitude of accommodation
Secondary Outcome Measures
Rate of adverse events
Full Information
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
Learn more about this trial
Feasibility Study of Laser Treatment of the Crystalline Lens to Correct Presbyopia
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