Visual Performance After RESTOR Implantation

Hospital Oftalmologico de Brasilia

Status and phase

Completed

Phase 4

Conditions

Refractive Assessment

Treatments

Procedure: RESTOR IOL

Study type

Interventional

Funder types

Other

Identifiers

NCT01065064

HOB-01/09

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

45 to 85 years old

Volunteers

Accepts Healthy Volunteers

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