- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01061281
Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
January 13, 2012 updated by: Innovative Medical
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months after post cataract surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Cape Coral, Florida, United States
- Farrell Tyson
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or greater
- Bilateral cataracts for which phacoemulsification extraction 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
- Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
- Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for both eyes
- Preoperative corneal astigmatism of 1.0 D or less
- Clear intraocular media other than cataract
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion Criteria:
- Use of systemic or ocular medications that may affect vision
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- Subjects with diabetes mellitus
- Uncontrolled systemic or ocular disease
- History of ocular trauma or prior ocular surgery
- 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 20/30 or worse
- Subjects who may be expected to require retinal laser treatment or other surgical intervention
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
- Requiring an intraocular lens < 15.0 or > 26.0 diopters
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tecnis MF IOL
|
20 patients enrolled with the Tecnis MF IOL.
|
Active Comparator: Crystalens AO IOL
|
20 patients enrolled with the Crystalens AO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Refraction
Time Frame: 1 year
|
1 year
|
Distance Visual Acuities
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
February 1, 2010
First Submitted That Met QC Criteria
February 2, 2010
First Posted (Estimate)
February 3, 2010
Study Record Updates
Last Update Posted (Estimate)
January 18, 2012
Last Update Submitted That Met QC Criteria
January 13, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tecnis MF/Crystalens
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aphakia
-
Beaver-Visitec International, Inc.Active, not recruitingEye Diseases | Cataract | Lens Opacities | Postcataract AphakiaUnited States
-
DAVID HAUSERUnknown
-
Sohag UniversityRecruitingAphakia, PostcataractEgypt
-
Debbie S. Kuo, MDAlcon ResearchRecruitingAphakia, PostcataractUnited States
-
Beaver-Visitec International, Inc.CompletedAphakia, Postcataract | Cataract; Eye DiseaseGermany, France, Spain
-
Medical University of ViennaRecruitingLens Luxation | IOL Subluxation | IOL Opacification | Aphakia - No Lens CapsuleAustria
-
Cutting Edge SASNot yet recruiting
-
Hoya Surgical Optics, Inc.CompletedAphakiaUnited States
-
RxSight, Inc.RecruitingCataract | AphakiaUnited States
Clinical Trials on Tecnis MF IOL
-
Innovative MedicalCompletedTo Collect Information About Visual Outcomes and Participant SatisfactionUnited States
-
Alcon ResearchCompleted
-
Innovative MedicalCompletedCataractUnited States
-
Johnson & Johnson Surgical Vision, Inc.Completed
-
University of TriesteCompleted
-
Mark Packer, MD, FACSAbbott Medical OpticsCompleted
-
Center For SightScience in VisionCompleted
-
Abbott Medical OpticsCompleted
-
Bucci Laser Vision InstituteCompletedCataract | Patient Satisfaction | IOLUnited States
-
Abbott Medical OpticsCompleted