Clinical trial NCT00845520: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Lead sponsor: Calhoun Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2 medical device study
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
timeFrame: 6 months post-operative
Secondary outcomes:
measure: Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)
timeFrame: 6 months post operative
Other outcomes:
measure: Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better
timeFrame: 12 months
Locations:
city: Los Altos
country: United States
facility: Altos Eye Physicians
state: California
city: Los Angeles
country: United States
facility: Maloney Vision Institute
state: California
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Leawood
country: United States
facility: Discover Vision Centers
state: Kansas
city: Chesterfield
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Tijuana
country: Mexico
facility: CODET Vision Institute
state: Zona Rio
Study officials:
affiliation: Emory Eye Center
name: R. Doyle Stulting, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: