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

Phase 4

• Conditions: Cataracts
• Interventions: Device: Hoya AF-1 IOL; Device: Revital vision

• Registration Number: NCT01382641
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hoya AF-1 IOL	Hoya AF-1 IOL	-
Revital Vision	Revital vision	-

Primary Outcome Measures

Name	Time	Method
Measuring Ocular Dominance	3 months
Overall post surgical outcomes	3 months

Secondary Outcome Measures

Name	Time	Method
Measuring visual acuities	3 months

Trial Locations

Locations (1)

McDonald Eye Associates, PA; 🇺🇸 Fayetteville, Arkansas, United States