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

Cataracts Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845520
• Other study ID #: CSP 002-00
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: March 2013

Study information

• Verified date: June 2018
• Source: Calhoun Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• Lens implantation +1.00 D postop target
Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
• Lens implantation -1.00 D postop target
Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
• Lens implantation 0.00 D postop target
Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.

Locations

Country	Name	City	State
Mexico	CODET Vision Institute	Tijuana	Zona Rio
United States	Pepose Vision Institute	Chesterfield	Missouri
United States	Price Vision Group	Indianapolis	Indiana
United States	Discover Vision Centers	Leawood	Kansas
United States	Altos Eye Physicians	Los Altos	California
United States	Maloney Vision Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Calhoun Vision, Inc.

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better	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.	12 months
Primary	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.	6 months post-operative
Secondary	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.	6 months post operative