Status:
COMPLETED
Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)
Lead Sponsor:
Abbott Medical Optics
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an...
Detailed Description
The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in th...
Eligibility Criteria
Inclusion
- Visual potential of 20/30 or better in each study eye
- Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)
- Naturally dilated pupil size (in dim light) \> 4.0 mm (with no dilation medications) for each study eye
- Preoperative corneal astigmatism of 1.0 D or less
Exclusion
- Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
- Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)
- Uncontrolled systemic or ocular disease
- History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention
- Presence of ocular pathology other than cataract such as:
- Amblyopia or strabismus
- Corneal abnormalities
- Pupil abnormalities
- Capsule or zonule abnormalities
- Intraocular inflammation
- Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)
- Requiring an intraocular lens outside the study diopter range
- Contact lens usage prior to study procedure (time interval dependent upon contact lens type)
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT00747565
Start Date
November 1 2004
End Date
November 1 2008
Last Update
February 4 2025
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