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

Status unconfirmed · Phase 4

Conditions studied: Cataracts

In brief

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.

Key facts

Study ID

NCT01382641

Run by

Innovative Medical

People needed

20

Starts

2010-09-01

Expected to finish

2011-12-01

Last updated by the study team

2011-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• McDonald Eye Associates, PA — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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