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OpenTrials
Completed

NCT Number: NCT00758550

Visual Function After Bilateral Implantation of AcrySof® Toric

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.

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Key information

Conditions

Visual Function

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alcon Call Center

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AcrySof® Toric IOL

Device

AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

AcrySof Natural

Device

AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

Primary outcomes

  1. Uncorrected Visual Acuity (UCVA)

    Time frame: 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 outcomes

  1. Questionnaire Results

    Time frame: 6 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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
First posted
Sep 25, 2008
Registry last updated
Mar 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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