Visual Performance After RESTOR Implantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Visual Performance After Implantation of an Aspheric Multifocal Diffractive Intraocular Lens|
- To evaluate distance, intermediate, and near vision after aspheric multifocal diffractive AcrySof® ReSTOR SN6AD1 intraocular lens (IOL) implantation. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Patients with cataract that had phacoemulsification and AcrySof® ReSTOR IOL implantation.
Procedure: RESTOR IOL
The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's AcrySof® ReSTOR® intraocular lens (IOL) for cataract patients with and without presbyopia. This innovative lens uses a revolutionary apodized diffractive technology to give patients a full range of quality vision (near, intermediate and distance) that greatly increases their independence from glasses after surgery
Other Name: RESTOR IQ MULTIFOCAL IOL
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065064
|Hospital Oftalmologico de Brasilia|
|Brasilia, DF, Brazil, 70200670|
|Principal Investigator:||PATRICK F TZELIKIS, MD, PhD||HOB; HBDF; UFMG|