Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 3, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 18, 2012
January 1, 2012
1.8 years
February 1, 2010
January 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Refraction
1 year
Distance Visual Acuities
1 year
Study Arms (2)
Tecnis MF IOL
ACTIVE COMPARATORCrystalens AO IOL
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Farrell Tyson
Cape Coral, Florida, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 3, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
January 18, 2012
Record last verified: 2012-01