N/A N=600 Randomized Single-blind Treatment

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

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT01496066 ↗

Enrolled (actual)

600

Serious AEs

8.7%

Results posted

Mar 2018

Primary outcome: Primary: Percent Reduction in Manifest Cylinder — 74.6; 19.9 percent reduction in manifest cylinder

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LAL (Light Adjustable Lens) and Light Deliver Device (LDD) (Device); Monofocal control IOL (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Calhoun Vision, Inc.
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Reduction in Manifest Cylinder	74.6; 19.9	—
PRIMARY Percent Absolute Reduction in MRSE	51.5; 10.4	—
PRIMARY Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop	96.1	—
SECONDARY Uncorrected Visual Acuity 20/20 or Better	70.1; 36.3	<.0001 sig
SECONDARY Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)	73.4; 18.6	<.0001 sig
SECONDARY Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)	77.5; 23.1	<.0001 sig
SECONDARY Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively	55.2; 27.2	.0318 sig
SECONDARY Mean BSCVA	-0.066; -0.029	—

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 = 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01496066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.