AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01605877
First received: May 22, 2012
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] in Japanese cataract patients.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Intraocular Lens Model SN6AD2

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Uncorrected Decimal VA (5 m) [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Uncorrected Decimal VA (50 cm) [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Best Corrected Decimal VA (5 m) [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Best Corrected Decimal VA (50 cm) [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Distance-Corrected Decimal VA (50 cm) [ Time Frame: Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.


Secondary Outcome Measures:
  • Uncorrected Decimal VA (1 m) [ Time Frame: Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested binocularly unaided at a distance of 1 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Distance Corrected Decimal VA (1 m) [ Time Frame: Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested binocularly using a chart. Distance-corrected VA at 1 m is the VA at 1 m measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Uncorrected Decimal VA (40 cm) [ Time Frame: Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested binocularly unaided at a distance of 40 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Distance Corrected Decimal VA (40 cm) [ Time Frame: Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested binocularly using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Uncorrected Decimal VA at Best Distance [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart at the distance of best near vision (cm) as decided by the participant. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Mean Best Distance (cm) for Uncorrected Decimal Near VA [ Time Frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided using a chart. The participant indicated the distance (cm) at which best near vision was attained.

  • Mean Best Distance (cm) for Distance Corrected Decimal Near VA [ Time Frame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ] [ Designated as safety issue: No ]
    VA was tested monocularly at Day 1-2, Day 7-14, Day 30-60, Day 120-180, and Day 330-420 and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction using a chart. The participant indicated the distance (cm) at which best near vision was attained.

  • Best Corrected Far (3 m) Contrast Sensitivity [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    Far contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 3 m using the Vector Vision CSV 1000 illuminated box (one site) and the Vision Contrast Test System (other site). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). For CSV 1000, contrast sensitivity was not measured at spatial frequency 1.5 cpd because there was no option for this frequency. Raw scores were transformed to logMar (logarithm of the minimum angle of resolution) units. A higher numeric value represents better contrast sensitivity.

  • Best Corrected Near (46 cm) Contrast Sensitivity [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    Near contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 46 cm using the Functional Acuity Contrast Test (FACT). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). Raw scores were transformed to logMar units. A higher numeric value represents better contrast sensitivity.

  • Mean Defocus Decimal VA (5 m) [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction at a distance of 5 m using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.

  • Percentage of Participants With Positive Response, Stereoscopic Vision Test [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    Stereopsis (the ability to perceive depth and 3-dimensional structure) was assessed binocularly under well-lit conditions at best distance using the Stereo Optical Company, Inc., Original Stereo Fly Test and polarized viewers. The participant was shown a series of symbols, with a positive response defined as correct identification of the 3-dimensional symbol. Responses were recorded for 3 symbols: Fly (easiest to perceive), animal, and circle (hardest to perceive).

  • Percentage of Participants With Positive Response, Quality of Life Questions [ Time Frame: Day 120-180 from second eye implantation ] [ Designated as safety issue: No ]
    The participant completed a questionnaire, indicating (yes/no) if he/she experienced visual difficulty in every-day activities while not wearing spectacles. A positive response was defined as, "Yes=visual difficulty."


Enrollment: 70
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SN6AD2
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

Detailed Description:

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 8 postoperative visits (each eye examined at Day 1-2, Day 7-14, and Day 30-60, with binocular visits at Day 120-180 and Day 330-420 after the second implantation). The second implantation occurred within 30 days of the first.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign informed consent;
  • Diagnosed with bilateral cataracts;
  • Planned cataract removal by phacoemulsification;
  • Potential postoperative visual acuity of 0.5 decimal or better in both eyes;
  • Preoperative astigmatism ≤ 1.5 diopter;
  • Clear intraocular media other than cataract in study eyes;
  • Calculated lens power within the available range;
  • Able to undergo second eye surgery within 30 days of the first eye surgery;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Significant irregular corneal aberration as demonstrated by corneal topography;
  • Any inflammation or edema (swelling) of the cornea;
  • Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.5 decimal;
  • Diabetic retinopathy;
  • Previous refractive surgery, retinal detachment, corneal transplant;
  • Glaucoma;
  • Pregnancy;
  • Currently participating in another investigational drug or device study;
  • Exclusion criteria during surgery;
  • 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: NCT01605877

Locations
Japan
Tokyo Dental College Suidobashi Hospital
Chiyoda-ku, Tokyo, Japan, 101-0061
Hayashi Eye Hospital
Fukuoka, Japan, 812-0011
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Hiroshi Kodama Alcon Japan, Ltd.
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01605877     History of Changes
Other Study ID Numbers: J-11-037
Study First Received: May 22, 2012
Results First Received: May 8, 2015
Last Updated: May 26, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Institutional Review Board

Keywords provided by Alcon Research:
Cataracts
Intraocular lens
Multifocal
Presbyopia

ClinicalTrials.gov processed this record on July 01, 2015