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

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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.

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 Phase
Cataract Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD) Device: Monofocal control IOL Not Applicable

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
Actual Primary Completion Date : June 2016
Actual 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 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.


  2. 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.


  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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).



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
Results First Posted: March 5, 2018
Last Update Posted: March 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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