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Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism

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: NCT01496066
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Calhoun Vision, Inc.

Brief Summary:
The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.

Condition or disease Intervention/treatment
Cataract Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD) Device: Monofocal control IOL

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 3 medical device study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Multi-Center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
Study Start Date : December 2011
Primary Completion Date : June 2016
Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: LAL
LAL implanted
Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
LAL implanted and adjusted with LDD
Active Comparator: Monofocal control
Monofocal control IOL implanted
Device: Monofocal control IOL
Commercially available monofocal intraocular lens (IOL)



Primary Outcome Measures :
  1. Percent reduction in manifest cylinder [ Time Frame: 6 months ]
    Percent reduction in manifest cylinder at 6 months postoperatively compared between LAL and monofocal control

  2. Percent mean absolute reduction in MRSE [ Time Frame: 6 months ]
    Percent mean absolute reduction in manifest refraction spherical equivalent (MRSE) by subject compared between LAL and monofocal control

  3. Rotation of LAL [ Time Frame: 6 months ]
    Rotation of the meridian of the LAL



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing cataract surgery and be willing to have LAL or commercially available IOL implanted
  • Pre-operative regular corneal astigmatism of >= 0.75 diopters and <= 2.0 diopters
  • Best spectacle corrected visual acuity reduced to 20/40 or worse with or without glare
  • Projected best spectacle corrected visual acuity of 20/20 or better
  • Clear intraocular media other than cataract
  • Potentially good vision in fellow eye
  • Fully dilated pupil of >= 7.0 mm

Exclusion Criteria:

  • Zonular laxity or dehiscence
  • Pseudoexfoliation
  • Age related macular degeneration
  • Retinal degenerative disorder
  • Diabetes with any evidence of retinopathy
  • Glaucomatous optic neuropathy, uveitis, significant anterior segment pathology, keratoconus
  • Corneal dystrophy, previous corneal or intraocular surgery
  • Complications during cataract surgery
  • Serious co-morbid conditions
  • Systemic medications that my increase UV sensitivity
  • Irregular astigmatism

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): NCT01496066


Locations
United States, Arkansas
Vold Vision
Fayetteville, Arkansas, United States, 72704
United States, California
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505
United States, Florida
Newsom Eye
Sebring, Florida, United States, 33870
United States, Illinois
Arbor Centers for Eye Care
Orland Park, Illinois, United States, 60467
United States, Indiana
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
United States, Iowa
Jones Eye Clinic
Sioux City, Iowa, United States, 51104
United States, Kansas
Discover Vision & Laser Center
Leawood, Kansas, United States, 66211
United States, Minnesota
Minnesota Eye Consultants, PA
Bloomington, Minnesota, United States, 55431
United States, Missouri
Ophthalmology Consultants, Ltd.
Saint Louis, Missouri, United States, 63131
United States, New Hampshire
EyeSight Ophthalmic Services, PA
Somersworth, New Hampshire, United States, 03878
United States, North Carolina
Carolina Vision Center
Fayetteville, North Carolina, United States, 28304
United States, Ohio
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141
United States, South Dakota
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Eye Consultants of Texas
Grapevine, Texas, United States, 76051
Focal Point Vision
San Antonio, Texas, United States, 78229
United States, Utah
Hoopes Vision
Draper, Utah, United States, 84020
Sponsors and Collaborators
Calhoun Vision, Inc.

Responsible Party: Calhoun Vision, Inc.
ClinicalTrials.gov Identifier: NCT01496066     History of Changes
Other Study ID Numbers: CSP-002-03
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors