- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01001117
Laser Treatment of the Crystalline Lens
April 14, 2011 updated by: LensAR Incorporated
A Prospective Single-Center Clinical Trial to Evaluate the Feasibility of Laser Treatment of the Crystalline Lens in Subjects Having Elected to Undergo Lens Extraction and Intraocular Lens Implantation
The use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to evaluate the feasibility of the LensAR laser system to surgically intervene within the crystalline lens.
The primary goal of this initial study is to establish safety parameters as compared with conventional phacoemulsification procedures, and to evaluate the ability to provide an accurate and consistent anterior capsular opening (capsulotomy).
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Mexico City, Mexico, DF 04030
- Asociacion Para Evitar La Cuguera en Mexico IAP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 foldable monofocal IOL implantation (ideally of the same type), and then elect to have the LensAR laser surgery.
- Subjects must be willing and able to return for scheduled follow-up examinations for a minimum of 12 months after surgery.
- Central 8 mm of clear cornea without vascularization.
Exclusion Criteria:
- Subjects with prior anterior segment or vitreo-retinal surgical intervention in the eye to be treated.
- Subjects with lenticular cataracts with nuclear grading greater than Grade 4 on the LOCS III scale.
- Subjects who cannot attain ocular dilation of 7.0 mm.
- Subjects with anterior segment pathology in the eye to be treated that is not directly improved by lens extraction and IOL implantation.
- Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be treated.
- Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be treated.
- Subjects with a history of severe dry eye not responding to therapy.
- Subjects with macular degeneration, history of retinal detachment, or any other fundus findings that would pose a risk to safety or an acceptable visual outcome in the eye to be treated.
- Subjects with a history of herpes zoster or herpes simplex keratitis.
- Subjects who have a history of steroid-responsive rise in intraocular pressure, glaucoma, or are a glaucoma suspect.
- Subjects with diabetic retinopathy, autoimmune disease, connective tissue disease, pseudoexfoliation syndrome, or clinically significant atopic syndrome.
- Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immuno-compromised subjects.
- Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of ocular pathology including ocular allergy.
- Subjects using systemic medications with significant ocular side effects.
- Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
- Subjects with known sensitivity to planned study concomitant medications.
- Subjects who are participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laser treated
Eye treated with LensAR Laser System
|
Use of laser for cataract surgery
Other Names:
|
Active Comparator: Control Eye
Contralateral eye treated with conventional phaco-emulsification
|
Phaco-emulsification cataract surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Capsulotomy a. Ease of opening b. Achievement of intended shape and size
Time Frame: Time of Surgery
|
Time of Surgery
|
Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification
Time Frame: Time of surgery
|
Time of surgery
|
Posterior capsule rupture < 10% occurrence rate
Time Frame: Time of Surgery
|
Time of Surgery
|
Less than 5% of eyes should lose more than two lines of BSCVA
Time Frame: 3 months post-operative
|
3 months post-operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ramon Naranjo, MD, Asociación para Evitar la Ceguera en Mexico IAP
- Principal Investigator: Jorge VIllar, MD, Asociación para Evitar la Ceguera en Mexico IAP
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
October 1, 2009
Study Completion (Anticipated)
April 1, 2011
Study Registration Dates
First Submitted
October 22, 2009
First Submitted That Met QC Criteria
October 22, 2009
First Posted (Estimate)
October 23, 2009
Study Record Updates
Last Update Posted (Estimate)
April 15, 2011
Last Update Submitted That Met QC Criteria
April 14, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 52-00001-0000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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