Visual Performance After RESTOR Implantation

Phase 4

Completed

• Conditions: Refractive Assessment
• Interventions: Procedure: RESTOR IOL

• Registration Number: NCT01065064
• Lead Sponsor: Hospital Oftalmologico de Brasilia

Brief Summary

The purpose of this study is to evaluate the distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.

Detailed Description

To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.

Prospective study of 50 patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation. Uncorrected distance vision acuity (UDVA), corrected distance visual acuity (CDVA), distance-corrected near visual acuity (DCNVA), and distance-corrected intermediate visual acuity (DCIVA) were measured postoperatively. A patient-satisfaction and visual phenomena questionnaire was administered at the end of the study.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-02
• Study Completion: 2009-12
• Status Verified: 2010-02
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Last Update Submitted: 2010-02-08
• Study First Posted: 2010-02-09
• Last Update Posted: 2010-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Cataract
• Any race
• Either gender
• Diagnosis of cataracts both eyes
• Pre-existing physical conditions that could skew visual results, such as Diabetes, Retinal detachment, Macular degeneration, or Cancer
• Subjects must have < 1.00 diopter of astigmatism
• Biometry results for the Restore patients should target emmetropia or +0.25.

Exclusion Criteria

• Central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia
• Retinal abnormalities
• Diabetes mellitus steroid or immunosuppressive treatment
• Connective tissue diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RESTOR	RESTOR IOL	Patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation.

Primary Outcome Measures

Name	Time	Method
To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.	6 months

Trial Locations

Locations (1)

Hospital Oftalmologico de Brasilia; 🇧🇷 Brasilia, DF, Brazil