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



Status:Completed
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:40 - 80
Updated:7/1/2018
Start Date:December 2011
End Date:June 2016

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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

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.


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
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9731 165th Street
Orland Park, Illinois 60467
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4211 US Highway 27 South
Sebring, Florida 33870
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Sioux City, Iowa 51104
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