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Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)

Primary Purpose

Cataracts

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lens implantation +1.00 D postop target
Lens implantation -1.00 D postop target
Lens implantation 0.00 D postop target
Sponsored by
Calhoun Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts

Eligibility Criteria

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

Inclusion Criteria:

  • Pre-operative regular corneal astigmatism less than or equal to 1.00 diopters by keratometry.
  • Adults between the ages of 40 and 80 inclusive.
  • Cataract causing reduction in best spectacle-corrected visual acuity to a level of 20/32 or worse.
  • Best corrected visual acuity projected (by clinical estimate based upon past ocular history and retinal exam) to be 20/25 or better after cataract removal and IOL implantation.
  • Clear intraocular media other than cataract.
  • Potentially good vision in the fellow eye with BCVA 20/40 or better.
  • Willing and able to comply with the schedule for power adjustment/lock-in treatments and the schedule for follow-up visits.
  • Fully dilated pupil diameter of more than or equal to 7.0 mm.

Exclusion Criteria:

  • Zonular laxity or dehiscence.
  • Pseudoexfoliation.
  • Age related macular degeneration involving the presence of geographic atrophy or soft drusen.
  • Retinal degenerative disorder that is expected to cause future vision loss.
  • Diabetes with any evidence of retinopathy.
  • Evidence of glaucomatous optic neuropathy.
  • History of uveitis.
  • Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris coloboma.
  • Corneal pathology that is either progressive or sufficient to reduce BCVA to 20/25 or worse.
  • Keratoconus or suspected of having keratoconus.
  • Corneal dystrophy including basement membrane dystrophy.
  • Previous corneal or intraocular surgery
  • Systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, and phenothiazines.
  • Complications during cataract surgery including posterior capsule rupture, zonular rupture, radial capsulorhexis tear, vitreous loss, iris trauma, corneal complications or any intraoperative abnormality that may affect the postoperative pupillary dilation, or the centration or tilt of the intraocular lens.

Sites / Locations

  • Altos Eye Physicians
  • Maloney Vision Institute
  • Price Vision Group
  • Discover Vision Centers
  • Pepose Vision Institute
  • CODET Vision Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lens implantation +1.00 diopter (D) postop target

Lens implantation -1.00 D postop target

Lens implantation 0.00 D postop target

Arm Description

Lens implant power calculated for postoperative MRSE target of +1.00 D

Lens implant power calculated for postoperative MRSE target of -1.00 D

Lens implant power calculated for postoperative MRSE target of 0.00 D

Outcomes

Primary Outcome Measures

Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.

Secondary Outcome Measures

Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)
Improvement in uncorrected visual acuity (UCVA): For those best case eyes with a pre-light treatment UCVA of 20/50 or worse, 65% of eyes should have an uncorrected visual acuity of 20/40 or better at the refractive stable point after the adjustment and lock-in treatments. All three arms of the study had the same end point so the results were presented as one combined cohort.

Full Information

First Posted
February 13, 2009
Last Updated
June 6, 2018
Sponsor
Calhoun Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00845520
Brief Title
Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)
Official Title
A Prospective Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects Undergoing Cataract Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (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 primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and Light Delivery Device (LDD) in treating postoperative residual refractive error by providing a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the LDD.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Phase 2 medical device study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lens implantation +1.00 diopter (D) postop target
Arm Type
Experimental
Arm Description
Lens implant power calculated for postoperative MRSE target of +1.00 D
Arm Title
Lens implantation -1.00 D postop target
Arm Type
Experimental
Arm Description
Lens implant power calculated for postoperative MRSE target of -1.00 D
Arm Title
Lens implantation 0.00 D postop target
Arm Type
Experimental
Arm Description
Lens implant power calculated for postoperative MRSE target of 0.00 D
Intervention Type
Device
Intervention Name(s)
Lens implantation +1.00 D postop target
Other Intervention Name(s)
Light Delivery Device
Intervention Description
Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Intervention Type
Device
Intervention Name(s)
Lens implantation -1.00 D postop target
Other Intervention Name(s)
Light Delivery Device
Intervention Description
Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Intervention Type
Device
Intervention Name(s)
Lens implantation 0.00 D postop target
Other Intervention Name(s)
Light Delivery Device
Intervention Description
Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Primary Outcome Measure Information:
Title
Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
Description
Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.
Time Frame
6 months post-operative
Secondary Outcome Measure Information:
Title
Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)
Description
Improvement in uncorrected visual acuity (UCVA): For those best case eyes with a pre-light treatment UCVA of 20/50 or worse, 65% of eyes should have an uncorrected visual acuity of 20/40 or better at the refractive stable point after the adjustment and lock-in treatments. All three arms of the study had the same end point so the results were presented as one combined cohort.
Time Frame
6 months post operative
Other Pre-specified Outcome Measures:
Title
Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better
Description
Best Corrected Visual Acuity (BSCVA): The percentage of eyes achieving overall and best case BSCVA of 20/40 or better should be comparable to the FDA grid of historical controls for intraocular lenses. All three arms of the study had the same end point so the results were presented as one combined cohort.
Time Frame
12 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: Pre-operative regular corneal astigmatism less than or equal to 1.00 diopters by keratometry. Adults between the ages of 40 and 80 inclusive. Cataract causing reduction in best spectacle-corrected visual acuity to a level of 20/32 or worse. Best corrected visual acuity projected (by clinical estimate based upon past ocular history and retinal exam) to be 20/25 or better after cataract removal and IOL implantation. Clear intraocular media other than cataract. Potentially good vision in the fellow eye with BCVA 20/40 or better. Willing and able to comply with the schedule for power adjustment/lock-in treatments and the schedule for follow-up visits. Fully dilated pupil diameter of more than or equal to 7.0 mm. Exclusion Criteria: Zonular laxity or dehiscence. Pseudoexfoliation. Age related macular degeneration involving the presence of geographic atrophy or soft drusen. Retinal degenerative disorder that is expected to cause future vision loss. Diabetes with any evidence of retinopathy. Evidence of glaucomatous optic neuropathy. History of uveitis. Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris coloboma. Corneal pathology that is either progressive or sufficient to reduce BCVA to 20/25 or worse. Keratoconus or suspected of having keratoconus. Corneal dystrophy including basement membrane dystrophy. Previous corneal or intraocular surgery Systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, and phenothiazines. Complications during cataract surgery including posterior capsule rupture, zonular rupture, radial capsulorhexis tear, vitreous loss, iris trauma, corneal complications or any intraoperative abnormality that may affect the postoperative pupillary dilation, or the centration or tilt of the intraocular lens.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Doyle Stulting, MD, PhD
Organizational Affiliation
Emory Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altos Eye Physicians
City
Los Altos
State/Province
California
ZIP/Postal Code
94024
Country
United States
Facility Name
Maloney Vision Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Discover Vision Centers
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pepose Vision Institute
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
CODET Vision Institute
City
Tijuana
State/Province
Zona Rio
ZIP/Postal Code
22320
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Effectiveness of the Calhoun Vision Light Adjustable Intraocular Lens (LAL)

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