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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01684007
First received: September 10, 2012
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Cataracts
Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm) [ Time Frame: Day 90 from second eye implantation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm) [ Time Frame: Day 90 from second eye implantation ] [ Designated as safety issue: No ]
    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.


Enrollment: 112
Study Start Date: November 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bilateral
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
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
Active Comparator: Contralateral
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation
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
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
Multifocal IOL implanted for long-term use over the lifetime of the cataract patient

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684007

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Magda Michna, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01684007     History of Changes
Other Study ID Numbers: M-12-007
Study First Received: September 10, 2012
Results First Received: May 8, 2015
Last Updated: May 26, 2015
Health Authority: Germany: Ethics Commission
Netherlands: Independent Ethics Committee
Spain: Ethics Committee
Argentina: Human Research Bioethics Committee
Chile: Institutional Review Board

Keywords provided by Alcon Research:
Intraocular lens
Multifocal intraocular lens (MIOL)

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on July 30, 2015