Clinical trial NCT01496066: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Calhoun Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-21
Enrollment: 600
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 3 medical device study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Reduction in Manifest Cylinder
timeFrame: 6 months
measure: Percent Absolute Reduction in MRSE
timeFrame: 6 months
measure: Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop
timeFrame: 6 months
Secondary outcomes:
measure: Uncorrected Visual Acuity 20/20 or Better
timeFrame: 6 months
measure: Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)
timeFrame: 6 months
measure: Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)
timeFrame: 6 months
measure: Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively
timeFrame: 6 months
measure: Mean BSCVA
timeFrame: 6 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Sebring
country: United States
facility: Newsom Eye
state: Florida
city: Orland Park
country: United States
facility: Arbor Centers for Eye Care
state: Illinois
city: Indianapolis
country: United States
facility: Eye Surgeons of Indiana
state: Indiana
city: Sioux City
country: United States
facility: Jones Eye Clinic
state: Iowa
city: Leawood
country: United States
facility: Discover Vision & Laser Center
state: Kansas
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, PA
state: Minnesota
city: Saint Louis
country: United States
facility: Ophthalmology Consultants, Ltd.
state: Missouri
city: Somersworth
country: United States
facility: EyeSight Ophthalmic Services, PA
state: New Hampshire
city: Fayetteville
country: United States
facility: Carolina Vision Center
state: North Carolina
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Grapevine
country: United States
facility: Eye Consultants of Texas
state: Texas
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
city: Draper
country: United States
facility: Hoopes Vision
state: Utah
Study officials:
References: