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OpenTrials
Completed

NCT Number: NCT03224728

Spherical Aberration on the Optical of Two Different Aspherical Intraocular Lenses

Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

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

Inclusion criteria

  • Bilateral age-related cataract
  • Potential postoperative visual acuity of 1.0 Snellen
  • No relevant ocular pathology other than cataract
  • Written informed consent to surgery and participation in the study

Exclusion criteria

  • Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases
  • Optical media disturbances due to: corneal and vitreal opacity, PEX
  • Preceding ocular trauma or ocular surgery within 6 months
  • Inability to cooperate
  • Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)

Treatment and study plan

Intraocular lens

Device

Primary outcomes

  1. Modulation transfer function (MTF) at 3 months after surgery

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Hospital Hietzing

Other

Registry information

Official study title

Effect of Spherical Aberration on the Optical Quality After Implantation of Two Different Aspherical Intraocular Lenses

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2017
Registry last updated
Jul 21, 2017

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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