Status:
COMPLETED
Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens Aspheric Optic (AO)
Lead Sponsor:
Innovative Medical
Conditions:
To Collect Information About Visual Outcomes and Participant Satisfaction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants pr...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria for Part 1:
- Age 18 or greater
- Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
- Visual potential of 20/30 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) \> 3.5 mm (with no dilation medications) for both eyes
- Preoperative corneal astigmatism of 1.5 D or less
- Clear intraocular media other than cataract
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
- Inclusion Criteria for Part 2
- At least 18 years of age
- Underwent bilateral implantation with Crystalens AO at least 6 months previously
- Visual potential of 20/30 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) \> 3.5 mm (with no dilation medications) for both eyes
- Preoperative corneal astigmatism of 1.5 D or less
- Clear intraocular media other than cataract
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion
- Key Exclusion Criteria for Part 1:
- 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
- Patients with forme fruste keratoconus or keratoconus
- 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
- Exclusion Criteria for Part 2
- 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
- Patients with forme fruste keratoconus or keratoconus
- 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)
- Requiring an intraocular lens \<15.0 or \>26.0 diopters Exclusion Criteria for Part 2
- 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
- Patients with forme fruste keratoconus or keratoconus
- 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)
- Requiring an intraocular lens \<15.0 or \>26.0 diopters
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01191229
Start Date
July 1 2010
End Date
June 1 2012
Last Update
June 14 2012
Active Locations (1)
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1
JacksonEye
Lake Villa, Illinois, United States, 60046