Laser Treatment of the Crystalline Lens

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by LensAR Incorporated.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
LensAR Incorporated
ClinicalTrials.gov Identifier:
NCT01001117
First received: October 22, 2009
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Cataract
Device: LensAR laser surgery
Device: Phaco-emulsification cataract surgery
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by LensAR Incorporated:

Primary Outcome Measures:
  • Capsulotomy a. Ease of opening b. Achievement of intended shape and size [ Time Frame: Time of Surgery ] [ Designated as safety issue: No ]
  • Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
  • Posterior capsule rupture < 10% occurrence rate [ Time Frame: Time of Surgery ] [ Designated as safety issue: Yes ]
  • Less than 5% of eyes should lose more than two lines of BSCVA [ Time Frame: 3 months post-operative ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: October 2008
Estimated Study Completion Date: April 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by LensAR Incorporated

Additional 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
Study First Received: October 22, 2009
Last Updated: April 14, 2011
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by LensAR Incorporated:
Cataract
Capsulotomy
Capsulorrhexis
Phacoemulsification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 21, 2014