CataractsNCT01605877

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

A study testing AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] in people with Cataracts, run by Alcon Research at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Cataracts
What is being tested?: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 2 sitesJapan
Study dates: May 2012to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Show all 9Show fewer

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.

Who cannot join

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;

Show all 9Show fewer

Pregnancy;
Currently participating in another investigational drug or device study;
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Tokyo Dental College Suidobashi Hospital
Chiyoda-ku, Tokyo, 101-0061
Hayashi Eye Hospital
Fukuoka, Fukuoka, 812-0011

Other trials in Japan

About this study

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

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.

Read the 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.

Conditions: Cataracts
Being tested: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
Keywords: Cataracts, Intraocular lens, Multifocal, Presbyopia
Medical subject headings: Cataract, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]Device
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient

Study groups in NCT01605877
Study group	Role	What they receive
SN6AD2	Experimental	AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation Receives: Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (12)

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.
Measured: Day 120-180, Day 330-420
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.
Measured: Day 120-180, Day 330-420
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.
Measured: Day 120-180, Day 330-420
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.
Measured: Day 120-180, Day 330-420
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.
Measured: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
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.
Measured: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
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.
Measured: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
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.
Measured: Day 120-180 from second eye implantation
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.
Measured: Day 120-180 from second eye implantation
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.
Measured: Day 120-180 from second eye implantation
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).
Measured: Day 120-180 from second eye implantation
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."
Measured: Day 120-180 from second eye implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Dec 2013

First posted25 May 2012 (estimated)
Study startMay 2012
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01605877
Sponsor's protocol ID: J-11-037
Status last verified: Jun 2015
First submitted: 22 May 2012
Last updated: 7 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataracts trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Intraocular Lens Model SN6AD2
ClinicalTrials.gov ID: NCT01605877
Acronym / sponsor ID: J-11-037
Conditions: Cataracts
Keywords: Cataracts, Intraocular lens, Multifocal, Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 25 May 2012 (estimated)
Results: Posted 9 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SN6AD2	Experimental	Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	SN6AD2

Primary outcome

Uncorrected Decimal VA (5 m)
Time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
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
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
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
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
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.

12 secondary outcomes

Uncorrected Decimal VA (1 m)
Time frame: Day 120-180, Day 330-420
Distance Corrected Decimal VA (1 m)
Time frame: Day 120-180, Day 330-420
Uncorrected Decimal VA (40 cm)
Time frame: Day 120-180, Day 330-420
Distance Corrected Decimal VA (40 cm)
Time frame: Day 120-180, Day 330-420
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
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
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
Best Corrected Far (3 m) Contrast Sensitivity
Time frame: Day 120-180 from second eye implantation
Best Corrected Near (46 cm) Contrast Sensitivity
Time frame: Day 120-180 from second eye implantation
Mean Defocus Decimal VA (5 m)
Time frame: Day 120-180 from second eye implantation
Percentage of Participants With Positive Response, Stereoscopic Vision Test
Time frame: Day 120-180 from second eye implantation
Percentage of Participants With Positive Response, Quality of Life Questions
Time frame: Day 120-180 from second eye implantation

Results and safety

Results posted to the registry on 9 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SN6AD2	64	63

Primary outcome: Uncorrected Decimal VA (5 m)

Time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420. Number. Unit: participants

Measure	Preoperative n = 64	Day 1-2 n = 64	Day 7-14 n = 64	Day 30-60 n = 64	Day 120-180 n = 64	Day 330-420 n = 63
First Eye worse than 0.5 decimal	48	3	1	0	0	0
First Eye 0.5 to less than 0.7 decimal	9	9	6	9	7	6
First Eye 0.7 to less than1.0 decimal	6	22	17	19	20	13
First Eye 1.0 decimal or better	1	30	40	36	37	44
Second Eye worse than 0.5 decimal	49	7	1	0	0	0
Second Eye 0.5 to less than 0.7 decimal	5	7	8	7	6	3
Second Eye 0.7 to less than 1.0 decimal	8	21	17	21	17	22
Second Eye 1.0 decimal or better	2	29	38	36	41	38

Population analysed: This analysis population includes all implanted subjects.

Primary outcome: Uncorrected Decimal VA (50 cm)

Time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420. Number. Unit: participants

Measure	Preoperative n = 64	Day 1-2 n = 64	Day 7-14 n = 64	Day 30-60 n = 64	Day 120-180 n = 64	Day 330-420 n = 63
First Eye worse than 0.4 decimal	49	12	6	4	5	2
First Eye 0.4 decimal or better	15	52	58	60	59	61
Second Eye worse than 0.4 decimal	44	11	4	3	5	3
Second Eye 0.4 decimal or better	20	53	60	61	59	60
Binocular worse than 0.4 decimal	NA	NA	NA	2	2	0
Binocular 0.4 decimal or better	NA	NA	NA	62	62	63

Population analysed: This analysis population includes all implanted subjects.

Primary outcome: 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. Number. Unit: participants

Measure	Preoperative n = 64	Day 1-2 n = 64	Day 7-14 n = 64	Day 30-60 n = 64	Day 120-180 n = 64	Day 330-420 n = 63
First Eye worse than 0.5 decimal	22	0	0	0	0	0
First Eye 0.5 to less than 0.7 decimal	18	3	0	0	1	0
First Eye 0.7 to less than 1.0 decimal	10	14	3	3	2	4
First Eye 1.0 decimal or better	14	47	61	61	61	59
Second Eye worse than 0.5 decimal	15	0	0	0	0	0
Second Eye 0.5 to less than 0.7 decimal	11	0	0	0	0	0
Second Eye 0.7 to less than 1.0 decimal	17	17	3	2	1	2
Second Eye 1.0 decimal or better	21	47	61	62	63	61

Population analysed: This analysis population includes all implanted subjects.

Primary outcome: 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. Number. Unit: participants

Measure	Preoperative n = 64	Day 1-2 n = 64	Day 7-14 n = 64	Day 30-60 n = 64	Day 120-180 n = 64	Day 330-420 n = 63
First Eye worse than 0.5 decimal	22	7	1	0	0	1
First Eye 0.5 to less than 0.7 decimal	19	22	9	7	8	5
First Eye 0.7 to less than 1.0 decimal	12	30	38	39	35	32
First Eye 1.0 decimal or better	11	5	16	18	21	25
Second Eye worse than 0.5 decimal	11	4	0	0	1	1
Second Eye 0.5 to less than 0.7 decimal	19	22	6	3	4	4
Second Eye 0.7 to less than 1.0 decimal	17	28	43	42	37	28
Second Eye 1.0 decimal or better	17	10	15	19	22	30

Population analysed: This analysis population includes all implanted subjects.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from time of lens implantation for the duration of the study (May 9, 2012 to December 10, 2013). This reporting group includes all implanted subjects.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SN6AD2	3 of 64 (4.7%)	0 of 64 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hiroshi Kodama study director

Alcon Japan, Ltd.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] in people with Cataracts, run by Alcon Research at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uncorrected Decimal VA (5 m) (time frame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01605877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.