Clinical trial NCT01605877: AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] in Japan
Official title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Intraocular Lens Model SN6AD2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: Cataracts
Intraocular lens
Multifocal
Presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 70
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® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\] in Japanese cataract patients.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Uncorrected Decimal VA (5 m)
timeFrame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
measure: Uncorrected Decimal VA (50 cm)
timeFrame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
measure: Best Corrected Decimal VA (5 m)
timeFrame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
measure: Best Corrected Decimal VA (50 cm)
timeFrame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
measure: Distance-Corrected Decimal VA (50 cm)
timeFrame: Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420
Secondary outcomes:
measure: Uncorrected Decimal VA (1 m)
timeFrame: Day 120-180, Day 330-420
measure: Distance Corrected Decimal VA (1 m)
timeFrame: Day 120-180, Day 330-420
measure: Uncorrected Decimal VA (40 cm)
timeFrame: Day 120-180, Day 330-420
measure: Distance Corrected Decimal VA (40 cm)
timeFrame: Day 120-180, Day 330-420
measure: Uncorrected Decimal VA at Best Distance
timeFrame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
measure: Mean Best Distance (cm) for Uncorrected Decimal Near VA
timeFrame: Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
measure: Mean Best Distance (cm) for Distance Corrected Decimal Near VA
timeFrame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
measure: Best Corrected Far (3 m) Contrast Sensitivity
timeFrame: Day 120-180 from second eye implantation
measure: Best Corrected Near (46 cm) Contrast Sensitivity
timeFrame: Day 120-180 from second eye implantation
measure: Mean Defocus Decimal VA (5 m)
timeFrame: Day 120-180 from second eye implantation
measure: Percentage of Participants With Positive Response, Stereoscopic Vision Test
timeFrame: Day 120-180 from second eye implantation
measure: Percentage of Participants With Positive Response, Quality of Life Questions
timeFrame: Day 120-180 from second eye implantation
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: Hiroshi Kodama
role: STUDY_DIRECTOR
References: