Trial record 1 of 1 for:
"Alzheimer disease type 3"
Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
This study has been terminated.
(Postmarket study terminated as the SN6AD3 is no longer promoted.)
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00710905
First received: July 3, 2008
Last updated: November 21, 2011
Last verified: November 2011
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Purpose
The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3 |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Binocular Visual Acuity at Near, Intermediate and Distance [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
| Enrollment: | 50 |
| Study Start Date: | October 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ReSTOR
Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
|
Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3
Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye following cataract removal.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.
Exclusion Criteria:
- Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
- All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710905
Locations
| Canada, British Columbia | |
| Dr John Blaylock | |
| Abbotsford, British Columbia, Canada, V2S 5A1 | |
| Canada, Quebec | |
| Dr Dominique Meyer | |
| Quebec City, Quebec, Canada, G1S 1X6 | |
Sponsors and Collaborators
Alcon Research
Investigators
| Principal Investigator: | John Blaylock |
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00710905 History of Changes |
| Other Study ID Numbers: | ALCONsur002.08 |
| Study First Received: | July 3, 2008 |
| Results First Received: | October 4, 2011 |
| Last Updated: | November 21, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Alcon Research:
|
Cataract IOL ReSTOR Aspheric Bilateral cataract |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013