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

Relevance of Eye Dominance in the Selection of Patients Suitable for Treatment With Monovision After Cataract Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Cataracts
• Intervention / Treatment: Device: Hoya AF-1 IOL; Device: Revital vision

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Hoya AF-1 IOL	Device: Hoya AF-1 IOL; The patients will be assessed for three months
OTHER: Revital Vision	Device: Revital vision; The patients will be assessed for three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measuring Ocular Dominance	3 months
Overall post surgical outcomes	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Measuring visual acuities	3 months

Collaborators and Investigators

• Sponsor: Innovative Medical

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ANTICIPATED): December 1, 2011
• Study Completion (ANTICIPATED): December 1, 2011

Study Registration Dates

• First Submitted: June 3, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (ESTIMATE): June 27, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 5, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: Hoya AF-1