Cataract
Conditions
Brief summary
Comparison of postoperative visual acuity and spectacle independence between the Tecnis Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL
Interventions
DEVICETecnis Multifocal IOL
Presbyopia correcting IOL
DEVICEcrystalens Accommodating IOL
Presbyopia correcting IOL
Sponsors
Abbott Medical Optics
Mark Packer, MD, FACS
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ AO Accommodating IOL * Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye * Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes * Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy) * Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion criteria
* Ocular disease which could potentially limit uncorrected visual acuity or visual performance. * Use of systemic or ocular medications that may affect visual outcomes * Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.) * Uncontrolled systemic or ocular disease * History of ocular trauma * History of ocular surgery other than that required for inclusion in this study * 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 worse than 20/30 * 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 or abnormally shaped pupils)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual function | 3 months postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Use of spectacle correction and vision-related quality of life | 3 months postoperatively |
Countries
United States
Outcome results
None listed