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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01382641
First received: June 3, 2011
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Cataracts
 Device: Hoya AF-1 IOL
Device: Revital vision
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relevance of Eye Dominance in the Selection of Patients Suitable for Treatment With Monovision After Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Innovative Medical:

Primary Outcome Measures:
  • Measuring Ocular Dominance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Overall post surgical outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measuring visual acuities [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382641

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

No publications provided

Responsible Party: James McDonald, McDonald Eye Associates, PA
ClinicalTrials.gov Identifier: NCT01382641     History of Changes
Other Study ID Numbers: Hoya AF-1
Study First Received: June 3, 2011
Last Updated: October 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Medical:
Cataract surgery

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013