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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-03-31

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.

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Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 2 medical device study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lens implantation +1.00 diopter (D) postop target

Lens implant power calculated for postoperative MRSE target of +1.00 D

Group Type EXPERIMENTAL

Lens implantation +1.00 D postop target

Intervention Type DEVICE

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 implant power calculated for postoperative MRSE target of -1.00 D

Group Type EXPERIMENTAL

Lens implantation -1.00 D postop target

Intervention Type DEVICE

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 implant power calculated for postoperative MRSE target of 0.00 D

Group Type EXPERIMENTAL

Lens implantation 0.00 D postop target

Intervention Type DEVICE

Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.

Interventions

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Lens implantation +1.00 D postop target

Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.

Intervention Type 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.

Intervention Type DEVICE

Lens implantation 0.00 D postop target

Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.

Intervention Type DEVICE

Other Intervention Names

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Light Delivery Device Light Delivery Device Light Delivery Device

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No