A Clinical Outcome Study of Two Multifocal Intraocular Lenses (IOL) in Cataract Patients

Cataracts Clinical Trial

Official title:

Clinical Outcomes After Implantation of the AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (MIOL) in the Dominant Eye and Randomization of the AcrySof® IQ ReSTOR® +2.5 D or +3.0 D MIOL in the Fellow Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684007
• Other study ID #: M-12-007
• Status: Completed
• Phase: N/A
• First received: September 10, 2012
• Last updated: May 26, 2015
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionNetherlands: Independent Ethics CommitteeSpain: Ethics CommitteeArgentina: Human Research Bioethics CommitteeChile: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral implantation) at Month 3 following the second eye surgery.

Description:

Each subject will complete a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Day 30 and Day 90 after the second implantation). The second implantation will occur between 1 and 45 days of the first. If the first eye is not implanted during surgery, the second eye is not eligible. lf both eyes are not implanted with the assigned IOL, the subject will be followed for safety evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Willing and able to understand and sign informed consent, and attend postoperative examinations per protocol schedule;

• Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes;

• Willing to have second eye surgery within 45 days of first eye surgery;

• Expected postoperative astigmatism < 1.0 D in both eyes, as measured by keratometry;

• Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Refractive lens exchange (monocular DCVA of worse than 20/20, or = 0.06 logMAR). This exclusion did not apply to binocular (OU) measurement;

• Significant irregular corneal astigmatism as demonstrated by corneal topography;

• Severe degenerative visual disorders;

• Previous corneal surgery;

• Amblyopia;

• Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course of the study;

• History of corneal disease;

• Severe diabetic retinopathy;

• History of retinal detachment;

• Severe conditions or acute or chronic diseases or illnesses that, per investigator's clinical judgment, would increase the operative risk or confound the results of the study;

• Pregnant or planning pregnancy during course of study;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
• AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)	Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.	Day 90 from second eye implantation	No
Secondary	Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)	VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.	Day 90 from second eye implantation	No