N/A
Completed N=49
Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Source: ClinicalTrials.gov NCT01200511 ↗Enrolled (actual)
49
Serious AEs
14.3%
Results posted
Apr 2017
Primary outcomePrimary: Uncorrected Visual Acuity Across a Range of Distances at Month 6 — 0.05; 0.15; 0.09; 0.05 logMAR
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 AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uncorrected Visual Acuity Across a Range of Distances at Month 6 |
0.05; 0.15; 0.09; 0.05; 0.07; 0.04 | — |
| PRIMARY Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 |
0.00; 0.19; 0.14; 0.06; 0.04; 0.05 | — |
| PRIMARY Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 |
84.5; 92.9; 95.2 | — |
| SECONDARY Patient Reported Outcomes at Month 6 |
1.72; 1.65; 1.49; 1.21; 1.24; 1.20 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01200511). 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.