Clinical trial NCT01323777: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan
Official title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: Cataracts
Intraocular lens
Multifocal
Toric
Astigmatism
Presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-03-28
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Monocular Uncorrected Distance Decimal Visual Acuity
timeFrame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
measure: Monocular Uncorrected Near Decimal VA
timeFrame: Day 30-60, Day 120-180, Day 330-420
Secondary outcomes:
Other outcomes:
Locations:
city: Chiyoda-ku
country: Japan
facility: Tokyo Dental College Suidobashi Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Hayashi Eye Hospital
Study officials:
affiliation: Alcon Japan, Ltd.
name: Group Manager, Surgical
role: STUDY_DIRECTOR
References: