Clincosm LogoSign in Get a demo

Clinical Analysis of Two Toric Intraocular Lenses

Sponsor
Hospital Hietzing (Other)
Overall Status
Completed
CT.gov ID
NCT03371576
Collaborator
(none)
60
Enrollment
63
Actual Duration (Months)

Study Details

Study Description

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 Phase
  • Device: intraocular lenses

Study Design

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 :
Jun 1, 2012
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
2 different torical intraocular lenses

Device: intraocular lenses

Outcome Measures

Primary Outcome Measures

  1. uncorrected visual acuity [1 year]

    visual acuity in logMARon an ETDRS Chart

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital Hietzing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Lasta, Principal investigator, Hospital Hietzing
ClinicalTrials.gov Identifier:
NCT03371576
Other Study ID Numbers:
  • HHietzing
First Posted:
Dec 13, 2017
Last Update Posted:
Dec 13, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Lasta, Principal investigator, Hospital Hietzing
toric IOL
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Dec 13, 2017