Visual Function After Bilateral Implantation of AcrySof® Toric

Alcon

Status and phase: Completed; Phase 4

Conditions: Visual Function

Treatments: Device: AcrySof® Toric IOL; Device: AcrySof Natural

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758550

CM-06-17

Details and patient eligibility

About

The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.

Enrollment: 60 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bilateral cataracts
• 40~80 years of age
• 4 Days - 1 Week interval between a single patient's surgery
• dilated pupil size (in dim light) ≥ 4.0 mm
• Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters
• 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

Exclusion criteria

• Preoperative ocular pathology
• Previous intraocular or corneal surgery
• An increased risk for complications which could require vitreoretinal surgery
• Corneal irregularities
• Corneal opacities
• Current contact lens usage(within 6 months prior to first surgery)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

AcrySof Toric IOL

Experimental group

Description:

AcrySof Toric Intraocular Lens (IOL)

Treatment:

Device: AcrySof® Toric IOL

AcrySof Natural IOL

Active Comparator group

Description:

AcrySof Natural Intraocular Lens (IOL)

Treatment:

Device: AcrySof Natural