MedPath

Visual Function After Bilateral Implantation of AcrySof® Toric

Phase 4
Completed
Conditions
Visual Function
Interventions
Device: AcrySof® Toric IOL
Device: AcrySof Natural
Registration Number
NCT00758550
Lead Sponsor
Alcon Research
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AcrySof Toric IOLAcrySof® Toric IOLAcrySof Toric Intraocular Lens (IOL)
AcrySof Natural IOLAcrySof NaturalAcrySof Natural Intraocular Lens (IOL)
Primary Outcome Measures
NameTimeMethod
Uncorrected Visual Acuity (UCVA)6 Months after surgery

Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures
NameTimeMethod
Questionnaire Results6 Months

Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).

Trial Locations

Locations (1)

Alcon Call Center

🇺🇸

Fort Worth, Texas, United States

© Copyright 2025. All Rights Reserved by MedPath