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

Innovative Medical

Status and phase: Unknown; Phase 4

Conditions: Cataracts

Treatments: Device: Revital vision; Device: Hoya AF-1 IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01382641

Hoya AF-1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Hoya AF-1 IOL

Other group

Treatment:

Device: Hoya AF-1 IOL

Revital Vision

Other group

Treatment:

Device: Revital vision