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
Results First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Calhoun Vision, Inc.

December 15, 2011
December 21, 2011
December 29, 2017
March 5, 2018
March 5, 2018
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 from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.

    Only eyes that had cylinder in the range of treatment (>=0.75 D) were included in the analysis. Therefore the number of participants analyzed for this outcome measure will not match the overall number of participants in the study.

  • Percent Absolute Reduction in MRSE [ Time Frame: 6 months ]

    Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.

    Any eyes that had an MRSE of zero at Pre-Adjustment were excluded since it is not possible to divide by zero. Therefore the number participants analyzed for this outcome will differ from the number of overall participants in the study.

  • Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop [ Time Frame: 6 months ]
    Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined. The overall number of participants analyzed differs from the other out outcome measures because some photographs were unusable due to inadequate lighting, user error, or equipment failure.
Not Provided
Complete list of historical versions of study NCT01496066 on ClinicalTrials.gov Archive Site
  • Uncorrected Visual Acuity 20/20 or Better [ Time Frame: 6 months ]
    Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively.
  • Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D) [ Time Frame: 6 months ]
    Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately.
  • Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D) [ Time Frame: 6 months ]
    Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group. The results only include eyes that had greater than 1.25D of refractive cylinder at Pre-Adjustment in the LAL group/17-21 days postoperative in the control group
  • Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively [ Time Frame: 6 months ]
    For eyes with <0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group.
  • Mean BSCVA [ Time Frame: 6 months ]
    Mean BSCVA for the "best case" cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta).
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 Applicable
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
Not Provided
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, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01496066
CSP-002-03
No
Not Provided
Plan to Share IPD: No
Calhoun Vision, Inc.
Calhoun Vision, Inc.
Not Provided
Not Provided
Calhoun Vision, Inc.
February 2018

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