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Clinical Trials/NCT01065064
NCT01065064
Completed
Phase 4

Visual Performance After Implantation of an Aspheric Multifocal Diffractive Intraocular Lens

Hospital Oftalmologico de Brasilia1 site in 1 country50 target enrollmentJanuary 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Refractive Assessment
Sponsor
Hospital Oftalmologico de Brasilia
Enrollment
50
Locations
1
Primary Endpoint
To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation.
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
December 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hospital Oftalmologico de Brasilia

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 6 months

Study Sites (1)

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