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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
Monofocal control IOL
Sponsored by
Calhoun Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vold Vision
  • Jules Stein Eye Institute
  • Wolstan & Goldberg Eye Associates
  • Newsom Eye
  • Arbor Centers for Eye Care
  • Eye Surgeons of Indiana
  • Jones Eye Clinic
  • Discover Vision & Laser Center
  • Minnesota Eye Consultants, PA
  • Ophthalmology Consultants, Ltd.
  • EyeSight Ophthalmic Services, PA
  • Carolina Vision Center
  • Cleveland Eye Clinic
  • Vance Thompson Vision
  • Eye Consultants of Texas
  • Focal Point Vision
  • Hoopes Vision

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LAL

Monofocal control

Arm Description

LAL implanted

Monofocal control IOL implanted

Outcomes

Primary Outcome Measures

Percent Reduction in Manifest Cylinder
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.
Percent Absolute Reduction in MRSE
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, the +1.00 is the sphere and the -1.00 is the cylinder in this example. 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.
Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
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.

Secondary Outcome Measures

Uncorrected Visual Acuity 20/20 or Better
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)
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)
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.
Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
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
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).

Full Information

First Posted
December 15, 2011
Last Updated
May 30, 2018
Sponsor
Calhoun Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01496066
Brief Title
Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
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 Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calhoun Vision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Phase 3 medical device study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LAL
Arm Type
Experimental
Arm Description
LAL implanted
Arm Title
Monofocal control
Arm Type
Active Comparator
Arm Description
Monofocal control IOL implanted
Intervention Type
Device
Intervention Name(s)
LAL (Light Adjustable Lens) and Light Deliver Device (LDD)
Intervention Description
LAL implanted and adjusted with LDD
Intervention Type
Device
Intervention Name(s)
Monofocal control IOL
Intervention Description
Commercially available monofocal intraocular lens (IOL)
Primary Outcome Measure Information:
Title
Percent Reduction in Manifest Cylinder
Description
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.
Time Frame
6 months
Title
Percent Absolute Reduction in MRSE
Description
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, the +1.00 is the sphere and the -1.00 is the cylinder in this example. 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.
Time Frame
6 months
Title
Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Uncorrected Visual Acuity 20/20 or Better
Description
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.
Time Frame
6 months
Title
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)
Description
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.
Time Frame
6 months
Title
Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)
Description
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.
Time Frame
6 months
Title
Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
Description
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.
Time Frame
6 months
Title
Mean BSCVA
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Facility Name
Jules Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Newsom Eye
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870
Country
United States
Facility Name
Arbor Centers for Eye Care
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60467
Country
United States
Facility Name
Eye Surgeons of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Jones Eye Clinic
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Discover Vision & Laser Center
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Minnesota Eye Consultants, PA
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Ophthalmology Consultants, Ltd.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
EyeSight Ophthalmic Services, PA
City
Somersworth
State/Province
New Hampshire
ZIP/Postal Code
03878
Country
United States
Facility Name
Carolina Vision Center
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Eye Consultants of Texas
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Focal Point Vision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hoopes Vision
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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