Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL

Study Overview
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Brief Summary
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Comparison of postoperative visual acuity and spectacle independence between the Tecnis Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL

Official Title
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Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence With Bilateral Implantation of the Tecnis Multifocal (TMF) Intraocular Lens or Crystalens AO (CAO) Intraocular Lens

Conditions
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Cataract

Intervention / Treatment
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* Device: Tecnis Multifocal IOL
* Device: crystalens Accommodating IOL


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Tecnis Multifocal IOL|Presbyopia correcting IOL|
|Device: crystalens Accommodating IOL|Presbyopia correcting IOL|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual function |  | 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of spectacle correction and vision-related quality of life |  | 3 months postoperatively |