Prospective Clinical Trial of the LensAR Laser System
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedApril 15, 2011
April 1, 2011
1.6 years
November 13, 2009
April 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Completeness and ease of opening of capsulotomy
Day 0 (Surgery)
Reduced need for ultrasound phacoemulsification compared to control eye
Day 0 (surgery)
Rate of adverse events
3 months
Study Arms (2)
Laser Treatment
EXPERIMENTALPhacoemulsifcation
ACTIVE COMPARATORInterventions
Use of standard techniques for capsulotomy and lens fragmentation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asociacion para Evitar la Ceguera en Mexico IAP
Mexico City, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 13, 2009
First Posted
November 17, 2009
Study Start
November 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
April 15, 2011
Record last verified: 2011-04