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Clinical Analysis of Two Toric Intraocular Lenses

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ClinicalTrials.gov Identifier: NCT03371576
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Lasta, Hospital Hietzing

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Cataract IOL Device: intraocular lenses

Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Two Toric IOL´s With Different Haptic Design: Optical Quality After 1 Year
Actual Study Start Date : June 1, 2012
Actual Primary Completion Date : August 1, 2015
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort Intervention/treatment
2 different torical intraocular lenses Device: intraocular lenses


Outcome Measures
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Primary Outcome Measures :
  1. uncorrected visual acuity [ Time Frame: 1 year ]
    visual acuity in logMARon an ETDRS Chart


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cataract on both eyes.
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Lasta, Principal investigator, Hospital Hietzing
ClinicalTrials.gov Identifier: NCT03371576    
Other Study ID Numbers: HHietzing
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Lasta, Hospital Hietzing:
toric IOL
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases