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

• Sponsor: Innovative Medical (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01382641
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: Hoya AF-1 IOL; Device: Revital vision	Phase 4

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: Dec 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Measuring Ocular Dominance [3 months]

2. Overall post surgical outcomes [3 months]

Secondary Outcome Measures

1. Measuring visual acuities [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McDonald Eye Associates, PA	Fayetteville	Arkansas	United States

Sponsors and Collaborators

• Innovative Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01382641
• Other Study ID Numbers: Hoya AF-1
• First Posted: Jun 27, 2011
• Last Update Posted: Oct 6, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by , ,: Cataract surgery
• Additional relevant MeSH terms: Cataract; Capsule Opacification

Study Results

No Results Posted as of Oct 6, 2011