N/A Completed N=31 Other

Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

Cataract · Presbyopia · Corneal Astigmatism

Source: ClinicalTrials.gov NCT02176343 ↗

Enrolled (actual)

Serious AEs

9.7%

Results posted

Jun 2017

Primary outcomePrimary: Mean Percent Reduction in Cylinder — 60.94 percent change

Summary

The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percent Reduction in Cylinder	60.94	—
PRIMARY Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D	67.7	—
PRIMARY Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D	100.0	—
PRIMARY Mean Uncorrected Distance Visual Acuity	0.07	—
PRIMARY Mean Uncorrected Near Visual Acuity	0.38	—
PRIMARY Mean Uncorrected Intermediate Visual Acuity	0.25	—
PRIMARY Mean Best Corrected Distance Visual Acuity (BCDVA)	-0.03	—
PRIMARY Mean IOL Rotation	3.74	—

Eligibility Criteria

Inclusion Criteria

Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);
Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;
Must complete a visit within 10 days after IOL implantation;
Successful capsular bag implantation with no surgical complications;
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;
Ocular or intraocular infection or inflammation at the time of the preoperative visit;
Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;
Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;
Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;
Known history of Type 1 or 2 diabetes for more than 5 years;
Any ocular or systemic co-morbidity at the preoperative visit;
Pregnant at the preoperative visit or at the time of Postoperative Visit 2;
Preoperative corneal astigmatism ≤ 0.50 D;
Participation in another clinical study at the preoperative visit or at the time of the final study visit;
Other protocol-specified exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02176343). 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.