N/A N=64 Treatment

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

Cataracts

Bottom Line

View on ClinicalTrials.gov: NCT01605877 ↗

Enrolled (actual)

Serious AEs

4.7%

Results posted

Jun 2015

Primary outcome: Primary: Uncorrected Decimal VA (5 m) — 48; 3; 1; 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] (Device)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Uncorrected Decimal VA (5 m)	48; 3; 1; 0; 0; 0	—
PRIMARY Uncorrected Decimal VA (50 cm)	49; 12; 6; 4; 5; 2	—
PRIMARY Best Corrected Decimal VA (5 m)	22; 0; 0; 0; 0; 0	—
PRIMARY Best Corrected Decimal VA (50 cm)	22; 7; 1; 0; 0; 1	—
PRIMARY Distance-Corrected Decimal VA (50 cm)	48; 4; 4; 2; 16; 60	—
SECONDARY Uncorrected Decimal VA (1 m)	0; 0; 8; 3; 20; 22	—
SECONDARY Distance Corrected Decimal VA (1 m)	3; 0; 4; 3; 24; 26	—
SECONDARY Uncorrected Decimal VA (40 cm)	3; 2; 61; 61	—
SECONDARY Distance Corrected Decimal VA (40 cm)	2; 2; 62; 61	—
SECONDARY Uncorrected Decimal VA at Best Distance	52; 13; 6; 4; 5; 3	—
SECONDARY Mean Best Distance (cm) for Uncorrected Decimal Near VA	40.5; 46.9; 47.3; 47.2; 47.3; 48.5	—
SECONDARY Mean Best Distance (cm) for Distance Corrected Decimal Near VA	48.2; 49.5; 48.6; 49.1; 49.4; 48.2	—
SECONDARY Best Corrected Far (3 m) Contrast Sensitivity	NA; 1.760; 1.889; 2.047; 2.026; 2.080	—
SECONDARY Best Corrected Near (46 cm) Contrast Sensitivity	1.825; 1.933; 1.739; 1.311; 0.856	—
SECONDARY Mean Defocus Decimal VA (5 m)	0.44; 0.65; 0.85; 1.11; 1.43; 1.16	—
SECONDARY Percentage of Participants With Positive Response, Stereoscopic Vision Test	100.0; 93.8; 85.9	—
SECONDARY Percentage of Participants With Positive Response, Quality of Life Questions	89.1; 81.3; 10.9; 7.8; 60.9; 1.6	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01605877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.