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

NCT ID: NCT01496066

Last Updated: 2018-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 3 medical device study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LAL

LAL implanted

Group Type EXPERIMENTAL

LAL (Light Adjustable Lens) and Light Deliver Device (LDD)

Intervention Type DEVICE

LAL implanted and adjusted with LDD

Monofocal control

Monofocal control IOL implanted

Group Type ACTIVE_COMPARATOR

Monofocal control IOL

Intervention Type DEVICE

Commercially available monofocal intraocular lens (IOL)

Interventions

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LAL (Light Adjustable Lens) and Light Deliver Device (LDD)

LAL implanted and adjusted with LDD

Intervention Type DEVICE

Monofocal control IOL

Commercially available monofocal intraocular lens (IOL)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Calhoun Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vold Vision

Fayetteville, Arkansas, United States

Site Status

Jules Stein Eye Institute

Los Angeles, California, United States

Site Status

Wolstan & Goldberg Eye Associates

Torrance, California, United States

Site Status

Newsom Eye

Sebring, Florida, United States

Site Status

Arbor Centers for Eye Care

Orland Park, Illinois, United States

Site Status

Eye Surgeons of Indiana

Indianapolis, Indiana, United States

Site Status

Jones Eye Clinic

Sioux City, Iowa, United States

Site Status

Discover Vision & Laser Center

Leawood, Kansas, United States

Site Status

Minnesota Eye Consultants, PA

Bloomington, Minnesota, United States

Site Status

Ophthalmology Consultants, Ltd.

St Louis, Missouri, United States

Site Status

EyeSight Ophthalmic Services, PA

Somersworth, New Hampshire, United States

Site Status

Carolina Vision Center

Fayetteville, North Carolina, United States

Site Status

Cleveland Eye Clinic

Brecksville, Ohio, United States

Site Status

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Eye Consultants of Texas

Grapevine, Texas, United States

Site Status

Focal Point Vision

San Antonio, Texas, United States

Site Status

Hoopes Vision

Draper, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CSP-002-03

Identifier Type: -

Identifier Source: org_study_id

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