N/A
Completed N=24
A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
Source: ClinicalTrials.gov NCT01225926 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Sep 2013
Primary outcomePrimary: Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 — 0.089; 0.225 logMAR
Summary
The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3 |
0.089; 0.225 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to understand and sign an informed consent;
- Willing and able to attend post-operative examinations per protocol schedule;
- In good ocular health, with the exception of cataracts;
- Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
- Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
- In good ocular health, with the exception of cataracts;
- Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Previous corneal surgery;
- Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
- Planned multiple procedures during cataract/IOL implantation surgery;
- Ocular disease and/or condition that may compromise study results;
- Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
- Pregnant or planning pregnancy during course of study;
- Participation in any other investigational study within 30 days prior to enrolment;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01225926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.