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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects Undergoing Cataract Extraction

Conditions
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Cataracts

Intervention / Treatment
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* Device: Lens implantation +1.00 D postop target
* Device: Lens implantation -1.00 D postop target
* Device: Lens implantation 0.00 D postop target


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase 2 medical device study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens implantation +1.00 diopter (D) postop target<br>Lens implant power calculated for postoperative MRSE target of +1.00 D | Device: Lens implantation +1.00 D postop target<br>* Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.<br>* Other names: Light Delivery Device;|
| Experimental: Lens implantation -1.00 D postop target<br>Lens implant power calculated for postoperative MRSE target of -1.00 D | Device: Lens implantation -1.00 D postop target<br>* Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.<br>* Other names: Light Delivery Device;|
| Experimental: Lens implantation 0.00 D postop target<br>Lens implant power calculated for postoperative MRSE target of 0.00 D | Device: Lens implantation 0.00 D postop target<br>* Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.<br>* Other names: Light Delivery Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |