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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01605877
• Other study ID #: J-11-037
• Status: Completed
• Phase: N/A
• First received: May 22, 2012
• Last updated: June 8, 2015
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Japan	Tokyo Dental College Suidobashi Hospital	Chiyoda-ku	Tokyo
Japan	Hayashi Eye Hospital	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420	No
Primary	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.	Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420	No
Primary	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.	Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420	No
Primary	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.	Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420	No
Primary	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.	Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420	No
Secondary	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.	Day 120-180, Day 330-420	No
Secondary	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.	Day 120-180, Day 330-420	No
Secondary	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.	Day 120-180, Day 330-420	No
Secondary	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.	Day 120-180, Day 330-420	No
Secondary	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.	Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420	No
Secondary	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.	Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420	No
Secondary	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.	Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420	No
Secondary	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.	Day 120-180 from second eye implantation	No
Secondary	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.	Day 120-180 from second eye implantation	No
Secondary	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.	Day 120-180 from second eye implantation	No
Secondary	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).	Day 120-180 from second eye implantation	No
Secondary	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."	Day 120-180 from second eye implantation	No