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Show Improved Vision With the HOYA AF-1 Aspheric Intraocular Lens After Cataract Surgery

NCT ID: NCT01382641

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

Brief Summary

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The doctors participating in this study are looking to show improved vision with the HOYA AF-1 aspheric intraocular lens after cataract surgery. They will also study the use of Revital Vision (neuro-sensory testing) in providing the highest potential for improved vision.

Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hoya AF-1 IOL

Group Type OTHER

Hoya AF-1 IOL

Intervention Type DEVICE

The patients will be assessed for three months

Revital Vision

Group Type OTHER

Revital vision

Intervention Type DEVICE

The patients will be assessed for three months.

Interventions

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Hoya AF-1 IOL

The patients will be assessed for three months

Intervention Type DEVICE

Revital vision

The patients will be assessed for three months.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients must desire to pursue some type of mono-vision fit, mono-vision lasik, or mono-vision cataract surgery with lens implant.
2. Patients must be candidates for intraocular lens implantation for the correction of aphakia following extracapsular cataract extraction by phaco-emulsification.
3. Patients must be candidates for bilateral implantation and desiring post-operative spectacle independence through targeted mono-vision.
4. Patients must have less than 1.50 diopters of corneal astigmatism
5. Patients must have the potential for best corrected visual acuity of 20/30 or better in each eye.
6. Patients must have the mental capacity to cooperate when undergoing a detailed postoperative refractive examination.
7. Patients must be an adult.
8. Patients must provide written informed consent for cataract surgery.
9. Patients must be willing and able to return for scheduled follow-up examinations for a period of 3 months (post-second eye) post-operatively.
10. Patients must be willing and able to provide feedback to various survey questions regarding overall satisfaction and ease of adaptation to mono-vision and range of vision, etc.

Exclusion Criteria

1. Patients with 1.50 diopters or more of corneal astigmatism
2. Patients requiring a lens power less than 6 D or greater than 30 D
3. Patients with any anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, corneal dystrophy or corneal degeneration, tear film deficiency, poor pupil dilation, etc.).
4. Patients with uncontrolled glaucoma or who require current treatment for glaucoma, or with visual field loss as a result of glaucoma.
5. Patients with retinal pathology or a history of retinal detachment.
6. Patients with proliferative diabetic retinopathy, macular degeneration, or other degenerative visual disorders.
7. Patients with a history of previous ocular surgery including corneal refractive surgery.
8. Patients with congenital bilateral cataracts.
9. Patients with marked microphthalmos or aniridia.
10. Patients who have only one functioning eye.
11. Patients who do not have the potential for visual acuity of 20/30 or better in each eye.
12. Patients lacking intact binocular vision.
13. Patients who do not have an intact capsulorhexis and posterior capsular bag at the time of cataract removal and lens implantation.
14. Patients who have incomplete or damaged zonules, or who have zonular rupture during cataract removal.
15. Patients with pupils greater than 7mm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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McDonald Eye Associates, PA

Locations

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McDonald Eye Associates, PA

Fayetteville, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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Hoya AF-1

Identifier Type: -

Identifier Source: org_study_id