Status:
COMPLETED
Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Lead Sponsor:
Alcon Research
Conditions:
Cataract
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the Acr...
Detailed Description
Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular ...
Eligibility Criteria
Inclusion
- Sign informed consent;
- Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
- Able to undergo second eye surgery within one month (30 days) of first eye surgery;
- Able to attend postoperative examinations per protocol schedule;
- Qualify for a AcrySof IQ Toric IOL in both eyes;
- Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
- Residual refractive cylinder of ≤0.5 D in both eyes;
- Good ocular health;
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
- Amblyopia;
- Previous corneal surgery;
- Clinically significant corneal endothelial dystrophy;
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
- History of retinal detachment;
- Pregnant or planning to become pregnant during course of study;
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01200511
Start Date
August 1 2010
End Date
September 1 2011
Last Update
July 2 2018
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