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Laser Treatment of the Crystalline Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01001117
Recruitment Status : Unknown
Verified April 2011 by LensAR Incorporated.
Recruitment status was:  Active, not recruiting
First Posted : October 23, 2009
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : October 2008
Primary Completion Date : October 2009
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

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 Name: LensAR Laser System
Active Comparator: Control Eye
Contralateral eye treated with conventional phaco-emulsification
Device: Phaco-emulsification cataract surgery
Phaco-emulsification cataract surgery
Other Name: Exact equipment varies


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, 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 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

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): NCT01001117


Locations
Mexico
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical & Regulatory Affairs, LensAR Inc
ClinicalTrials.gov Identifier: NCT01001117     History of Changes
Other Study ID Numbers: 52-00001-0000
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Keywords provided by LensAR Incorporated:
Cataract
Capsulotomy
Capsulorrhexis
Phacoemulsification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases