Aphakia Clinical Trial
Official title:
Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses
Verified date | January 2012 |
Source | Innovative Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Farrell Tyson | Cape Coral | Florida |
Lead Sponsor | Collaborator |
---|---|
Innovative Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Refraction | 1 year | No | |
Primary | Distance Visual Acuities | 1 year | No |
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