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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01382641
Recruitment Status : Unknown
Verified October 2011 by Innovative Medical.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2011
Last Update Posted : October 6, 2011
Information provided by:
Innovative Medical

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.

Condition or disease Intervention/treatment Phase
Cataracts Device: Hoya AF-1 IOL Device: Revital vision Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relevance of Eye Dominance in the Selection of Patients Suitable for Treatment With Monovision After Cataract Surgery
Study Start Date : September 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Hoya AF-1 IOL Device: Hoya AF-1 IOL
The patients will be assessed for three months

Revital Vision Device: Revital vision
The patients will be assessed for three months.

Primary Outcome Measures :
  1. Measuring Ocular Dominance [ Time Frame: 3 months ]
  2. Overall post surgical outcomes [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Measuring visual acuities [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01382641

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United States, Arkansas
McDonald Eye Associates, PA
Fayetteville, Arkansas, United States
Sponsors and Collaborators
Innovative Medical

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Responsible Party: James McDonald, McDonald Eye Associates, PA Identifier: NCT01382641     History of Changes
Other Study ID Numbers: Hoya AF-1
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011
Keywords provided by Innovative Medical:
Cataract surgery
Additional relevant MeSH terms:
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Capsule Opacification
Lens Diseases
Eye Diseases