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Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

A Six-months, Open-labelled Clinical Assessment of Visual Function After Bilateral Implantation of Arcysof ReSTOR Multifocal Intra-ocular Lens

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00758940
Enrollment
0
Registered
2008-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Outcomes

Keywords

Clinical, assessment, of visual, function, with the Acrysof ReSTOR, multifocal IOL

Brief summary

An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are at least 30 patients or as much as possible from the doctor's clinical practice perspective. 6 months follow-up after IOL implant in the 2nd eye

Interventions

DEVICEAcrysof ReSTOR multifocal IOL

Implanted into the study eye following cataract extraction surgery

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Able to complete all required postoperative visits; Planned cataract removal by phaco; 21 years of age or older, either gender or any race; potential postoperative visual acuity of 20/20; astigmatism ≦1.0D measured by keratometry in study eye(s);clear int

Exclusion criteria

* Signs of capsular tear, significant anterior chamber hyphema;zonular rupture; corneal pathology and refractive surgery;hypercritical patient; patients with unrealistic expectations in post-op VA; happy to wear glasses;occupational night drivers

Design outcomes

Primary

MeasureTime frame
Near,intermediate,distance visual acuitypre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery

Secondary

MeasureTime frame
contrast sensitivity6 month after 2nd eye surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026