Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction
This study has been completed.
Sponsor:
Medical University of South Carolina
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00720005
First received: July 18, 2008
Last updated: October 1, 2010
Last verified: October 2010
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Purpose
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Device: Aspheric Acrysof ReSTOR intraocular lens |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction |
Resource links provided by NLM:
Further study details as provided by Medical University of South Carolina:
Primary Outcome Measures:
- ETDRS uncorrected and best corrected visual acuity at distance, intermediate, and near, manifest refraction, distance corrected near visual acuity (DCNVA), and best near point (optimal reading distance). [ Time Frame: Preoperatively, 1, 3 and 6 months postoperatively ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- pupil size and contrast sensitivity under photopic and mesopic conditions wearing the best distance correction (the latter per eye and both eyes. Slit-lamp exam, eye dominance, reading speed test, and a quality of vision questionnaire. [ Time Frame: preoperatively, 1, 3, 6 month ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | September 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Aspheric Acrysof ResTOR Lens
Implantation of Aspheric Acrysof ResTOR
|
Device: Aspheric Acrysof ReSTOR intraocular lens
Bilateral implantation of Aspheric Acrysof ReSTOR
Other Name: Acrysof ReSTOR
|
Detailed Description:
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Subjects 18 years or older who had cataract surgery.
Criteria
Inclusion Criteria:
- Subject must have an age-related cataract in both eyes.
- 40 years of age or older.
- Patient must desire cataract extraction.
- Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
- Willing and able to comply with scheduled visits and other study procedures
Exclusion Criteria:
- Preoperative ocular pathology potentially affecting visual acuity.
- Keratometric astigmatism exceeding 1.50 diopters.
- Planned postoperative refraction for mono-vision.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
- Other ocular surgery at the time of the cataract extraction.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720005
Locations
| United States, South Carolina | |
| Storm Eye Institute, Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
Sponsors and Collaborators
Medical University of South Carolina
Investigators
| Principal Investigator: | Kerry D. Solomon, MD | Assistant Professor |
More Information
No publications provided
| Responsible Party: | Kerry D Solomon, MD, Storm Eye Institute - Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00720005 History of Changes |
| Other Study ID Numbers: | MRC-07-002 |
| Study First Received: | July 18, 2008 |
| Last Updated: | October 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medical University of South Carolina:
|
Cataract cataract extraction intraocular lens age related |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on June 18, 2013