Aphakia
Conditions
Keywords
Aphakia following refractive lensectomy to treat presbyopia
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.
Interventions
DEVICETecnis MF IOL
20 patients enrolled with the Tecnis MF IOL.
DEVICECrystalens AO IOL
20 patients enrolled with the Crystalens AO
Sponsors
Innovative Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Refraction | 1 year |
| Distance Visual Acuities | 1 year |
Countries
United States
Outcome results
None listed