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

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: NCT00845520
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Cataracts Device: Light Adjustable Intraocular Lens Device: Light Adjustable (LAL) intraocular lens requiring +1.00 D power adjustment Device: Light Adjustable (LAL) intraocular lens requiring -1.00 D power adjustment Device: Light Adjustable (LAL) intraocular lens requiring no (0.00 D) power adjustment

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 2 medical device study
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2009
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: +1.00 D adjustment
LAL implant power requiring LAL power adjustment of +1.00 D
Device: Light Adjustable Intraocular Lens
Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable intraocular lens. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
Other Name: Light Adjsutable Lens; LAL
Device: Light Adjustable (LAL) intraocular lens requiring +1.00 D power adjustment
Light Adjustable (LAL) intraocular lens requiring +1.00 D power adjustment with the Light Delivery Device (LDD)
Active Comparator: -1.00 D adjustment
LAL implant power requiring LAL power adjustment of -1.00 D
Device: Light Adjustable Intraocular Lens
Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable intraocular lens. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
Other Name: Light Adjsutable Lens; LAL
Device: Light Adjustable (LAL) intraocular lens requiring -1.00 D power adjustment
Light Adjustable (LAL) intraocular lens requiring -1.00 D power adjustment using the Light Delivery Device
Active Comparator: No adjustment
LAL implant power requiring no (0.0 D) LAL power adjustment
Device: Light Adjustable Intraocular Lens
Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable intraocular lens. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power.
Other Name: Light Adjsutable Lens; LAL
Device: Light Adjustable (LAL) intraocular lens requiring no (0.00 D) power adjustment
Light Adjustable (LAL) intraocular lens requiring no (0.00 D) power adjustment with the Light Delivery Device


Outcome Measures

Primary Outcome Measures :
  1. Achieved refractive correction [ Time Frame: 3 to 6 months ]

Eligibility Criteria

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:

  • 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.
Contacts and Locations

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): NCT00845520


Locations
United States, California
Altos Eye Physicians
Los Altos, California, United States, 94024
Maloney Vision Institute
Los Angeles, California, United States, 90024
United States, Kansas
Discover Vision Centers
Leawood, Kansas, United States, 66211
United States, Missouri
Pepose Vision Institute
Chesterfield, Missouri, United States, 63017
Sponsors and Collaborators
Calhoun Vision, Inc.
Investigators
Principal Investigator: R. Doyle Stulting, MD, PhD Emory Eye Center
More Information

Responsible Party: Calhoun Vision, Inc.
ClinicalTrials.gov Identifier: NCT00845520     History of Changes
Other Study ID Numbers: CSP 002-00
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases