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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

About this trial

This is an interventional treatment trial for Cataracts focused on measuring Cataracts, Intraocular lens, Multifocal, Presbyopia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tokyo Dental College Suidobashi Hospital
Hayashi Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SN6AD2

Arm Description

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation

Outcomes

Primary Outcome Measures

Uncorrected Decimal VA (5 m)

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)

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)

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)

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)

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)

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)

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)

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)

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

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

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

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

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

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)

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

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

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."

Full Information

NCT ID

NCT01605877

First Posted

May 22, 2012

Last Updated

June 8, 2015

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01605877

Brief Title

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

Official Title

Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Intraocular Lens Model SN6AD2

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataracts

Keywords

Cataracts, Intraocular lens, Multifocal, Presbyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SN6AD2

Arm Type

Experimental

Arm Description

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation

Intervention Type

Device

Intervention Name(s)

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

Intervention Description

Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient

Primary Outcome Measure Information:

Title

Uncorrected Decimal VA (5 m)

Description

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.

Time Frame

Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420

Title

Uncorrected Decimal VA (50 cm)

Description

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.

Time Frame

Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420

Title

Best Corrected Decimal VA (5 m)

Description

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.

Time Frame

Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420

Title

Best Corrected Decimal VA (50 cm)

Description

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.

Time Frame

Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420

Title

Distance-Corrected Decimal VA (50 cm)

Description

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.

Time Frame

Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420

Secondary Outcome Measure Information:

Title

Uncorrected Decimal VA (1 m)

Description

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.

Time Frame

Day 120-180, Day 330-420

Title

Distance Corrected Decimal VA (1 m)

Description

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.

Time Frame

Day 120-180, Day 330-420

Title

Uncorrected Decimal VA (40 cm)

Description

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.

Time Frame

Day 120-180, Day 330-420

Title

Distance Corrected Decimal VA (40 cm)

Description

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.

Time Frame

Day 120-180, Day 330-420

Title

Uncorrected Decimal VA at Best Distance

Description

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.

Time Frame

Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420

Title

Mean Best Distance (cm) for Uncorrected Decimal Near VA

Description

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.

Time Frame

Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420

Title

Mean Best Distance (cm) for Distance Corrected Decimal Near VA

Description

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.

Time Frame

Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420

Title

Best Corrected Far (3 m) Contrast Sensitivity

Description

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.

Time Frame

Day 120-180 from second eye implantation

Title

Best Corrected Near (46 cm) Contrast Sensitivity

Description

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.

Time Frame

Day 120-180 from second eye implantation

Title

Mean Defocus Decimal VA (5 m)

Description

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.

Time Frame

Day 120-180 from second eye implantation

Title

Percentage of Participants With Positive Response, Stereoscopic Vision Test

Description

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).

Time Frame

Day 120-180 from second eye implantation

Title

Percentage of Participants With Positive Response, Quality of Life Questions

Description

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."

Time Frame

Day 120-180 from second eye implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroshi Kodama

Organizational Affiliation

Alcon Japan, Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Tokyo Dental College Suidobashi Hospital

City

Chiyoda-ku

State/Province

Tokyo

ZIP/Postal Code

101-0061

Country

Japan

Facility Name

Hayashi Eye Hospital

City

Fukuoka

ZIP/Postal Code

812-0011

Country

Japan

Cataracts

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial