Prospective Clinical Trial of the LensAR Laser System
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by LensAR Incorporated.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
LensAR Incorporated
ClinicalTrials.gov Identifier:
NCT01014702
First Posted: November 17, 2009
Last Update Posted: April 15, 2011
Information provided by:
LensAR Incorporated
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Cataract | Device: LensAR Laser System Device: Conventional phacoemulsification | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity |
Resource links provided by NLM:
Further study details as provided by LensAR Incorporated:
Primary Outcome Measures:
- Completeness and ease of opening of capsulotomy [ Time Frame: Day 0 (Surgery) ]
- Reduced need for ultrasound phacoemulsification compared to control eye [ Time Frame: Day 0 (surgery) ]
- Rate of adverse events [ Time Frame: 3 months ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Laser Treatment |
Device: LensAR Laser System
Use of laser for capsulotomy and lens fragmentation
|
| Active Comparator: Phacoemulsifcation |
Device: Conventional phacoemulsification
Use of standard techniques for capsulotomy and lens fragmentation
|
Eligibility
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| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014702
Locations
| Mexico | |
| Asociacion para Evitar la Ceguera en Mexico IAP | |
| Mexico City, Mexico | |
Sponsors and Collaborators
LensAR Incorporated
More Information
| Responsible Party: | Keith Edwards, Director Clinical & Regulatory Affairs, LensAR Incorporated |
| ClinicalTrials.gov Identifier: | NCT01014702 History of Changes |
| Other Study ID Numbers: |
52-00006-000 |
| First Submitted: | November 13, 2009 |
| First Posted: | November 17, 2009 |
| Last Update Posted: | April 15, 2011 |
| Last Verified: | April 2011 |
Keywords provided by LensAR Incorporated:
|
Cataract Capsulotomy Capsulorrhexis lens fragmentation phacoemulsification |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |