Overview

This trial is active, not recruiting.

Condition cataract
Treatments lensar laser surgery, phaco-emulsification cataract surgery
Phase phase 2/phase 3
Sponsor LensAR Incorporated
Start date October 2008
End date October 2009
Trial size 75 participants
Trial identifier NCT01001117, 52-00001-0000

Summary

The use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Eye treated with LensAR Laser System
lensar laser surgery LensAR Laser System
Use of laser for cataract surgery
(Active Comparator)
Contralateral eye treated with conventional phaco-emulsification
phaco-emulsification cataract surgery Exact equipment varies
Phaco-emulsification cataract surgery

Primary Outcomes

Measure
Capsulotomy a. Ease of opening b. Achievement of intended shape and size
time frame: Time of Surgery
Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification
time frame: Time of surgery
Posterior capsule rupture < 10% occurrence rate
time frame: Time of Surgery
Less than 5% of eyes should lose more than two lines of BSCVA
time frame: 3 months post-operative

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title 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
Principal investigator Ramon Naranjo, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by LensAR Incorporated.