AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01323777
• Collaborator: (none)
• Enrollment: 65
• Locations: 2
• Arm: 1
• Duration (Months): 22
• Patients Per Site: 32.5
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace the natural lens in Japanese cataract patients.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL	N/A

Detailed Description

Eligible participants completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits: Day 1-2, Day 7-14, and Day 30-60 after each implantation, and Day 120-180 and Day 330-420 after second eye implantation. The second implantation occurred within 30 days of the first.The primary eye was defined as the eye with higher astigmatism, with the other eye defined as the secondary eye. If both eyes had the same level of astigmatism, the first implanted eye was set as the primary eye.

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR +3.0 AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation	Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL; Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient; Other Names: Models SND1T3, SND1T4, SND1T5, SND1T6

Outcome Measures

Primary Outcome Measures

1. Monocular Uncorrected Distance Decimal Visual Acuity [Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420]

   Visual acuity (VA) was tested monocularly (each eye separately) 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.

2. Monocular Uncorrected Near Decimal VA [Day 30-60, Day 120-180, Day 330-420]

   VA was tested monocularly unaided at a distance of 40 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sign informed consent;

• Diagnosed with bilateral cataracts;

• Planned cataract removal by phacoemulsification;

• Potential postoperative visual acuity of 0.6 decimal or better in both eyes;

• Preoperative astigmatism ≥ 0.75 diopter;

• Clear intraocular media other than cataract in study eyes;

• Calculated lens power and astigmatism within the available range;

• Pupil size greater than or equal to 6 mm after dilation;

• Able to undergo second eye surgery within 30 days of the first eye surgery;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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 0.6 decimal;

• Diabetic retinopathy;

• Previous refractive surgery, retinal detachment, corneal transplant;

• Glaucoma;

• Pregnant, nursing, or suspected of being pregnant;

• Currently participating in another investigational drug or device study;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tokyo Dental College Suidobashi Hospital	Chiyoda-ku	Tokyo	Japan	101-0061
2	Hayashi Eye Hospital	Fukuoka		Japan	812-0011

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Group Manager, Surgical, Alcon Japan, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01323777
• Other Study ID Numbers: J-10-050
• First Posted: Mar 28, 2011
• Last Update Posted: Jul 2, 2018
• Last Verified: Mar 1, 2017

• Keywords provided by Alcon Research: Cataracts; Intraocular lens; Multifocal; Toric; Astigmatism; Presbyopia
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 2 study sites located in Japan.
Pre-assignment Detail	This reporting group includes all implanted subjects (65).

Arm/Group Title	ReSTOR +3.0
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Period Title: Overall Study
STARTED	65
COMPLETED	65
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	ReSTOR +3.0
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Overall Participants	65
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.4 (9.9)
Age, Customized (participants) [Number]
<60 years	12 18.5%
60-69 years	24 36.9%
70-79 years	25 38.5%
≥ 80 years	4 6.2%
Sex: Female, Male (Count of Participants)
Female	50 76.9%
Male	15 23.1%
Region of Enrollment (participants) [Number]
Japan	65 100%

Outcome Measures

1. Primary Outcome

Title	Monocular Uncorrected Distance Decimal Visual Acuity
Description	Visual acuity (VA) was tested monocularly (each eye separately) 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	Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420

Outcome Measure Data

Analysis Population Description

This analysis population includes all implanted subjects.

Arm/Group Title	Day 1-2	Day 7-14	Day 30-60	Day 120-180	Day 330-420
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
Measure Participants	65	65	65	65	65
Primary eye worse than 0.5 decimal	3 4.6%	3 NaN	1 NaN	0 NaN	1 NaN
Primary eye 0.5 to less than 0.7 decimal	12 18.5%	4 NaN	6 NaN	3 NaN	5 NaN
Primary eye 0.7 to less than 1.0 decimal	29 44.6%	27 NaN	30 NaN	27 NaN	28 NaN
Primary eye 1.0 decimal or better	21 32.3%	31 NaN	28 NaN	35 NaN	31 NaN
Secondary eye worse than 0.5 decimal	5 7.7%	1 NaN	3 NaN	1 NaN	0 NaN
Secondary eye 0.5 to less than 0.7 decimal	14 21.5%	7 NaN	2 NaN	6 NaN	6 NaN
Secondary eye 0.7 to less than 1.0 decimal	21 32.3%	22 NaN	28 NaN	28 NaN	27 NaN
Secondary eye 1.0 decimal or better	25 38.5%	35 NaN	32 NaN	30 NaN	32 NaN

2. Primary Outcome

Title	Monocular Uncorrected Near Decimal VA
Description	VA was tested monocularly unaided at a distance of 40 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	Day 30-60, Day 120-180, Day 330-420

Outcome Measure Data

Analysis Population Description

This analysis population includes all implanted subjects.

Arm/Group Title	Day 30-60	Day 120-180	Day 330-420
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
Measure Participants	65	65	65
Primary eye worse than 0.4 decimal	1 1.5%	0 NaN	1 NaN
Primary eye 0.4 decimal or better	64 98.5%	65 NaN	64 NaN
Secondary eye worse than 0.4 decimal	1 1.5%	1 NaN	0 NaN
Secondary eye 0.4 decimal or better	64 98.5%	64 NaN	65 NaN

Adverse Events

Time Frame	This reporting group includes all implanted subjects.
Adverse Event Reporting Description	An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user or other persons regardless of whether or not the event has a causal relationship with the medical device(s) or test procedure(s) in the study. AEs were collected as solicited comments from the subject and as observations by the study Investigator as outlined in the protocol.
Arm/Group Title	ReSTOR +3.0
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
All Cause Mortality
	ReSTOR +3.0
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ReSTOR +3.0
	Affected / at Risk (%)	# Events
Total	8/65 (12.3%)
Cardiac disorders
Atrial fibrillation paroxysmal	1/65 (1.5%)
Infections and infestations
Endophthalmitis (Primary Eye)	1/65 (1.5%)
Injury, poisoning and procedural complications
Eighth rib fracture	1/65 (1.5%)
Spinal compression fracture	1/65 (1.5%)
Musculoskeletal and connective tissue disorders
Gonarthrosis	1/65 (1.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma hepatocellular	1/65 (1.5%)
Oropharyngeal cancer	1/65 (1.5%)
Nervous system disorders
Carotid artery stenosis	1/65 (1.5%)
Cerebral infarction	1/65 (1.5%)
Surgical and medical procedures
Secondary surgical intervention (Primary Eye)	2/65 (3.1%)
Other (Not Including Serious) Adverse Events
	ReSTOR +3.0
	Affected / at Risk (%)	# Events
Total	0/65 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.