Show Improved Vision With the HOYA AF-1 Aspheric Intraocular Lens After Cataract Surgery
This study is ongoing, but not recruiting participants.
Information provided by:
First received: June 3, 2011
Last updated: October 5, 2011
Last verified: October 2011
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.
Device: Hoya AF-1 IOL
Device: Revital vision
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Relevance of Eye Dominance in the Selection of Patients Suitable for Treatment With Monovision After Cataract Surgery
Primary Outcome Measures:
- Measuring Ocular Dominance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Overall post surgical outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measuring visual acuities [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Hoya AF-1 IOL
Device: Hoya AF-1 IOL
The patients will be assessed for three months
Device: Revital vision
The patients will be assessed for three months.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must desire to pursue some type of mono-vision fit, mono-vision lasik, or mono-vision cataract surgery with lens implant.
- Patients must be candidates for intraocular lens implantation for the correction of aphakia following extracapsular cataract extraction by phaco-emulsification.
- Patients must be candidates for bilateral implantation and desiring post-operative spectacle independence through targeted mono-vision.
- Patients must have less than 1.50 diopters of corneal astigmatism
- Patients must have the potential for best corrected visual acuity of 20/30 or better in each eye.
- Patients must have the mental capacity to cooperate when undergoing a detailed postoperative refractive examination.
- Patients must be an adult.
- Patients must provide written informed consent for cataract surgery.
- Patients must be willing and able to return for scheduled follow-up examinations for a period of 3 months (post-second eye) post-operatively.
- 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.
- Patients with 1.50 diopters or more of corneal astigmatism
- Patients requiring a lens power less than 6 D or greater than 30 D
- Patients with any anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, corneal dystrophy or corneal degeneration, tear film deficiency, poor pupil dilation, etc.).
- Patients with uncontrolled glaucoma or who require current treatment for glaucoma, or with visual field loss as a result of glaucoma.
- Patients with retinal pathology or a history of retinal detachment.
- Patients with proliferative diabetic retinopathy, macular degeneration, or other degenerative visual disorders.
- Patients with a history of previous ocular surgery including corneal refractive surgery.
- Patients with congenital bilateral cataracts.
- Patients with marked microphthalmos or aniridia.
- Patients who have only one functioning eye.
- Patients who do not have the potential for visual acuity of 20/30 or better in each eye.
- Patients lacking intact binocular vision.
- Patients who do not have an intact capsulorhexis and posterior capsular bag at the time of cataract removal and lens implantation.
- Patients who have incomplete or damaged zonules, or who have zonular rupture during cataract removal.
- Patients with pupils greater than 7mm
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382641
|McDonald Eye Associates, PA
|Fayetteville, Arkansas, United States |
No publications provided
||James McDonald, McDonald Eye Associates, PA
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 3, 2011
||October 5, 2011
||United States: Institutional Review Board
Keywords provided by Innovative Medical:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013