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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01382641
• Other study ID #: Hoya AF-1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 3, 2011
• Last updated: October 5, 2011
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2011
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Cataracts

Intervention

Device:
• Hoya AF-1 IOL
The patients will be assessed for three months
• Revital vision
The patients will be assessed for three months.

Locations

Country	Name	City	State
United States	McDonald Eye Associates, PA	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring Ocular Dominance		3 months	No
Primary	Overall post surgical outcomes		3 months	No
Secondary	Measuring visual acuities		3 months	No