Laser Treatment of the Crystalline Lens

Sponsor

LensAR Incorporated (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01001117

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: LensAR laser surgery Device: Phaco-emulsification cataract surgery	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Oct 1, 2009

Anticipated Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser treated Eye treated with LensAR Laser System	Device: LensAR laser surgery Use of laser for cataract surgery Other Names: LensAR Laser System
Active Comparator: Control Eye Contralateral eye treated with conventional phaco-emulsification	Device: Phaco-emulsification cataract surgery Phaco-emulsification cataract surgery Other Names: Exact equipment varies

Arm

Intervention/Treatment

Experimental: Laser treated

Eye treated with LensAR Laser System

Device: LensAR laser surgery

Use of laser for cataract surgery

Other Names:

LensAR Laser System

Active Comparator: Control Eye

Contralateral eye treated with conventional phaco-emulsification

Device: Phaco-emulsification cataract surgery

Phaco-emulsification cataract surgery

Other Names:

Exact equipment varies

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asociacion Para Evitar La Cuguera en Mexico IAP	Mexico City		Mexico	DF 04030

Sponsors and Collaborators

LensAR Incorporated

Investigators

Principal Investigator: Ramon Naranjo, MD, Asociacion Para Evitar La Ceguera en Mexico IAP
Principal Investigator: Jorge VIllar, MD, Asociacion Para Evitar La Ceguera en Mexico IAP