Show Improved Vision With the HOYA AF-1 Aspheric Intraocular Lens After Cataract Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Innovative Medical.
Recruitment status was Active, not recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 21, 2014