Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Primary Purpose
Aphakia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tecnis MF IOL
Crystalens AO IOL
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia focused on measuring Aphakia following refractive lensectomy to treat presbyopia
Eligibility Criteria
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
Sites / Locations
- Farrell Tyson
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tecnis MF IOL
Crystalens AO IOL
Arm Description
Outcomes
Primary Outcome Measures
Refraction
Distance Visual Acuities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01061281
Brief Title
Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Official Title
Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Innovative Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia
Keywords
Aphakia following refractive lensectomy to treat presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tecnis MF IOL
Arm Type
Active Comparator
Arm Title
Crystalens AO IOL
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Tecnis MF IOL
Intervention Description
20 patients enrolled with the Tecnis MF IOL.
Intervention Type
Device
Intervention Name(s)
Crystalens AO IOL
Intervention Description
20 patients enrolled with the Crystalens AO
Primary Outcome Measure Information:
Title
Refraction
Time Frame
1 year
Title
Distance Visual Acuities
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Farrell Tyson
City
Cape Coral
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
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