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OpenTrials
Completed

NCT Number: NCT01166971

A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Eye Center of North Florida, Panama City, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed with bilateral cataracts
  • candidate for presbyopic lens

Exclusion criteria

  • >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings
  • pre-existing conditions that could skew the results

Treatment and study plan

ReSTOR +3

Device

Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction

Tecnis MF

Device

Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction

Primary outcomes

  1. Defocus Curve

    Time frame: 3 months after surgery

    A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution".

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs

Important dates

Study start
2010
Primary completion
2011
First posted
Jul 21, 2010
Registry last updated
Nov 24, 2011

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

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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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