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OpenTrials
Completed

NCT Number: NCT03371576

Clinical Analysis of Two Toric Intraocular Lenses

Purpose: Comparison of two torical intraocular lenses with differents haptic design in patients with cataract.

Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes the Tecnis torical IOL (Abbott Medical Optics) or the AT Torbi torical 709 MB IOL (Zeiss Medical AG) were randomly implanted. Three months after surgery visual acuity, rotation stability and astigmatism correction were evaluated.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age related cataract on both eyes
  • Corneal astigmatism 1,0- 4,0 D
  • Potential postoperative visus 1,0
  • No other ocular pathology as cataract
  • Age 18 - 80
  • Written informed consent to surgery and participation in the study

Exclusion criteria

  • Pregnancy, breastfeeding
  • Amblyopy, diabetic retinopathy, uveitis or other relevant ophthalmologic diseases
  • Optical media disturbances due to: corneal and vitreal opacity, PEX
  • Irregular astigmatism measured with corneal topography (Visante-omni), keratoconus
  • ≥ 10 degrees difference between the axis of keratometry measurement of the IOL Master and the simulated K reading of the corneal topograph (Visante-omni)
  • Trauma, ocular surgery performed within 6 months
  • Traumatic cataract
  • Potential postoperative visus under 1,0

Treatment and study plan

intraocular lenses

Device

Primary outcomes

  1. uncorrected visual acuity

    Time frame: 1 year

    visual acuity in logMARon an ETDRS Chart

Sponsors and collaborators

Lead sponsor

Hospital Hietzing

Other

Registry information

Official study title

Comparison of Two Toric IOL´s With Different Haptic Design: Optical Quality After 1 Year

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Dec 13, 2017
Registry last updated
Dec 13, 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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