Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: Acrysof Natural ReSTOR SN60D3; Device: Acrysof Natural Monofocal SN60AT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759668

IT 06 01

Details and patient eligibility

About

The purpose of the study is:

• to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
• to assess patient satisfaction before and after implant

Enrollment: 35 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Written informed consent
• Age: ≥ 50 years ≤ 75 years
• Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
• Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
• Potential post operative Visual Acuity (VA) ≥ 20/40
• Second eye surgery to take place no longer than 45 days after the first implant

Exclusion:

• Irregular optical aberrations;
• Pupil diameter in scotopic conditions more than 6 mm
• Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
• Other exclusions as from ReSTOR Directions for Use (DFU)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 2 patient groups

SN60D3

Experimental group

Description:

AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3

Treatment:

Device: Acrysof Natural ReSTOR SN60D3

SN60AT

Active Comparator group

Description:

AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT

Treatment:

Device: Acrysof Natural Monofocal SN60AT