Back to resultsProspective Clinical Trial of the LensAR Laser System
Primary Purpose
Cataract
Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
LensAR Laser System
Conventional phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, Capsulotomy, Capsulorrhexis, lens fragmentation, phacoemulsification
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 and then elect to have the LensAR laser surgery as part of the procedure.
- Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
- Subjects must have central 7 mm of clear cornea without vascularization.
Exclusion Criteria:
- 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.
Sites / Locations
- Asociacion para Evitar la Ceguera en Mexico IAP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser Treatment
Phacoemulsifcation
Arm Description
Outcomes
Primary Outcome Measures
Completeness and ease of opening of capsulotomy
Reduced need for ultrasound phacoemulsification compared to control eye
Rate of adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01014702
Brief Title
Prospective Clinical Trial of the LensAR Laser System
Official Title
Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
LensAR Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Capsulotomy, Capsulorrhexis, lens fragmentation, phacoemulsification
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser Treatment
Arm Type
Experimental
Arm Title
Phacoemulsifcation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
LensAR Laser System
Intervention Description
Use of laser for capsulotomy and lens fragmentation
Intervention Type
Device
Intervention Name(s)
Conventional phacoemulsification
Intervention Description
Use of standard techniques for capsulotomy and lens fragmentation
Primary Outcome Measure Information:
Title
Completeness and ease of opening of capsulotomy
Time Frame
Day 0 (Surgery)
Title
Reduced need for ultrasound phacoemulsification compared to control eye
Time Frame
Day 0 (surgery)
Title
Rate of adverse events
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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 and then elect to have the LensAR laser surgery as part of the procedure.
Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
Subjects must have central 7 mm of clear cornea without vascularization.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Asociacion para Evitar la Ceguera en Mexico IAP
City
Mexico City
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Prospective Clinical Trial of the LensAR Laser System
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