Clinical Analysis of Two Toric Intraocular Lenses

December 12, 2017 updated by: Michael Lasta, Hospital Hietzing

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with cataract on both eyes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2 different torical intraocular lenses
Device: intraocular lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
uncorrected visual acuity
Time Frame: 1 year
visual acuity in logMARon an ETDRS Chart
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Hietzing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHietzing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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