Status:
COMPLETED
Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence
Lead Sponsor:
Innovative Medical
Conditions:
Visual Acuity
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in p...
Eligibility Criteria
Inclusion
- 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™ HD 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
- 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)
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01191502
Start Date
January 1 2010
End Date
September 1 2011
Last Update
October 6 2011
Active Locations (1)
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1
Oregon Health & Sciences University
Eugene, Oregon, United States, 97401