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

Primary Purpose

Cataracts

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hoya AF-1 IOL
Revital vision
Sponsored by
Innovative Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring Cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McDonald Eye Associates, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Hoya AF-1 IOL

Revital Vision

Arm Description

Outcomes

Primary Outcome Measures

Measuring Ocular Dominance
Overall post surgical outcomes

Secondary Outcome Measures

Measuring visual acuities

Full Information

First Posted
June 3, 2011
Last Updated
October 5, 2011
Sponsor
Innovative Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01382641
Brief Title
Show Improved Vision With the HOYA AF-1 Aspheric Intraocular Lens After Cataract Surgery
Official Title
Relevance of Eye Dominance in the Selection of Patients Suitable for Treatment With Monovision After Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Innovative Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Cataract surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hoya AF-1 IOL
Arm Type
Other
Arm Title
Revital Vision
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Hoya AF-1 IOL
Intervention Description
The patients will be assessed for three months
Intervention Type
Device
Intervention Name(s)
Revital vision
Intervention Description
The patients will be assessed for three months.
Primary Outcome Measure Information:
Title
Measuring Ocular Dominance
Time Frame
3 months
Title
Overall post surgical outcomes
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Measuring visual acuities
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
McDonald Eye Associates, PA
City
Fayetteville
State/Province
Arkansas
Country
United States

12. IPD Sharing Statement

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

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