We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

December 15, 2011
December 21, 2011
December 14, 2017
December 2011
June 2016   (Final data collection date for primary outcome measure)
  • Percent reduction in manifest cylinder [ Time Frame: 6 months ]
    Percent reduction in manifest cylinder at 6 months postoperatively compared between LAL and monofocal control
  • 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
  • Rotation of LAL [ Time Frame: 6 months ]
    Rotation of the meridian of the LAL
Not Provided
Complete list of historical versions of study NCT01496066 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Phase 3 medical device study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Cataract
  • Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
    LAL implanted and adjusted with LDD
  • Device: Monofocal control IOL
    Commercially available monofocal intraocular lens (IOL)
  • Experimental: LAL
    LAL implanted
    Intervention: Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
  • Active Comparator: Monofocal control
    Monofocal control IOL implanted
    Intervention: Device: Monofocal control IOL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01496066
CSP-002-03
No
Not Provided
Not Provided
Calhoun Vision, Inc.
Calhoun Vision, Inc.
Not Provided
Not Provided
Calhoun Vision, Inc.
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP