AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
This study is currently recruiting participants.
Verified June 2012 by Innovative Medical
Sponsor:
Innovative Medical
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT01278420
First received: August 27, 2010
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Device: Tecnis MF Device: ReSTOR |
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: | AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL |
Resource links provided by NLM:
MedlinePlus related topics:
Cataract
Drug Information available for:
Dipivefrin hydrochloride
U.S. FDA Resources
Further study details as provided by Innovative Medical:
Primary Outcome Measures:
- Refraction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Distance Visual Acuities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Near Visual Acuities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Intermediate Acuities [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Tecnis MF |
Device: Tecnis MF
30 subjects will be implanted with the Tecnis MF
|
| ReSTOR |
Device: ReSTOR
30 subjects will be implanted with ReSTOR
|
Detailed Description:
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age 18 or greater
- Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes
- Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
- Clear intraocular media other than cataract
- Normal OCT of the macula
- No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography
- No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
- Use of systemic or ocular medications that may affect vision
- Uncontrolled systemic or ocular disease
- History of ocular trauma
- History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)
- Amblyopia or strabismus
- Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse
- Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278420
Contacts
| Contact: Jenna Piel | 951-653-5566 | j.piel@imedsonline.com |
Locations
| United States, California | |
| Sansum- Santa Barbara medical foundation Clinic | Active, not recruiting |
| Santa Barbara, California, United States, 93101 | |
| United States, Florida | |
| Katzen Eye Care & Laser Center | Recruiting |
| Boynton Beach, Florida, United States, 33426 | |
| Principal Investigator: Larry Katzen, MD | |
| The Center for Excellence in Eye Care | Recruiting |
| Miami, Florida, United States, 33176 | |
| Principal Investigator: William Trattler, MD | |
| United States, Illinois | |
| Jackson Eye, SC | Recruiting |
| Lake Villa,, Illinois, United States, 60046 | |
| Principal Investigator: Mitch Jackson, MD | |
| United States, Indiana | |
| Eye Surgeons of Indiana | Recruiting |
| Indianapolis, Indiana, United States, 46256 | |
| Principal Investigator: Kevin Waltz, MD | |
| United States, Ohio | |
| Cleveland Eye Clinic | Recruiting |
| Breckville, Ohio, United States, 44141 | |
| Principal Investigator: Shamik Bafna, MD | |
Sponsors and Collaborators
Innovative Medical
Investigators
| Principal Investigator: | William Trattler, MD | The Center for Excellence in Eye Care |
| Principal Investigator: | Mitch Jackson, MD | Jackson Eye |
| Principal Investigator: | Larry Katzen, MD | Katzen Eye Care & Laser Center |
| Principal Investigator: | Kevin Waltz, MD | Eye Surgeons of Indiana |
| Principal Investigator: | Shamik Bafna, MD | Clevland Eye Clinic |
More Information
No publications provided
| Responsible Party: | William Trattler, The Center for Excellence in Eye Care |
| ClinicalTrials.gov Identifier: | NCT01278420 History of Changes |
| Other Study ID Numbers: | TMF vs Restor MF 3D |
| Study First Received: | August 27, 2010 |
| Last Updated: | June 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Innovative Medical:
|
Visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013