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

Cataracts Clinical Trial

Official title:

Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323777
• Other study ID #: J-10-050
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• 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 0.6 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.

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

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

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

External Links

•   Results from the Novartis Clinical Trial Results Website