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

NCT01382641 | Unknown Phase 4

• 1 other identifier: Hoya AF-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataracts

Keywords

Cataract surgery

Outcome Measures

Primary Outcomes (2)

• Measuring Ocular Dominance

  3 months

• Overall post surgical outcomes

  3 months

Secondary Outcomes (1)

• Measuring visual acuities

  3 months

Study Arms (2)

Hoya AF-1 IOL

OTHER

Device: Hoya AF-1 IOL

Revital Vision

OTHER

Device: Revital vision

Interventions

Hoya AF-1 IOL DEVICE

The patients will be assessed for three months

Hoya AF-1 IOL

Revital vision DEVICE

The patients will be assessed for three months.

Revital Vision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Innovative Medical: lead

Study Sites (1)

McDonald Eye Associates, PA

Fayetteville, Arkansas, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 27, 2011
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

US (1)