Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01510717
First received: January 12, 2012
Last updated: May 8, 2015
Last verified: May 2015
  Purpose

The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.


Condition Intervention
Cataracts
Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Device: AcrySof® IQ Monofocal IOL Model SN60WF

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.

  • Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 [ Time Frame: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation ] [ Designated as safety issue: Yes ]
    Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.

  • Photopic Contrast Sensitivity Without Glare at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: Yes ]
    Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

  • Photopic Contrast Sensitivity With Glare at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: Yes ]
    Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

  • Mesopic Contrast Sensitivity Without Glare at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: Yes ]
    Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

  • Mesopic Contrast Sensitivity With Glare at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: Yes ]
    Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.


Secondary Outcome Measures:
  • Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.

  • Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    VA was tested monocularly (each eye separately) 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, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.

  • Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses overall?"

  • Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses for seeing objects up close?"


Enrollment: 409
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multifocal IOL
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: Monofocal IOL
AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation
Device: AcrySof® IQ Monofocal IOL Model SN60WF
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Detailed Description:

Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of bilateral cataracts
  • Willing and able to complete all required postoperative visits
  • Calculated lens power within the available supply range
  • Planned cataract removal by phacoemulsification
  • Potential postoperative visual acuity of 0.2 logMAR or better in both eyes
  • Preoperative astigmatism less than 1.0 diopter
  • Clear intraocular media other than cataract in study eyes
  • Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR
  • Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Previous refractive surgery
  • Inflammation or edema of the cornea
  • Optic nerve atrophy
  • Pregnancy
  • Current participation in another investigational drug or device 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: NCT01510717

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: NCT01510717     History of Changes
Other Study ID Numbers: C-10-016
Study First Received: January 12, 2012
Results First Received: May 8, 2015
Last Updated: May 8, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Intraocular Lens
Monofocal
Multifocal

ClinicalTrials.gov processed this record on July 29, 2015