Status:
UNKNOWN
Laser Treatment of the Crystalline Lens
Lead Sponsor:
LensAR Incorporated
Conditions:
Cataract
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
The use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01001117
Start Date
October 1 2008
End Date
April 1 2011
Last Update
April 15 2011
Active Locations (1)
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1
Asociacion Para Evitar La Cuguera en Mexico IAP
Mexico City, Mexico, DF 04030