Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation

October 12, 2022 updated by: Prim. Prof. Dr. Oliver Findl, MBA
To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Recruiting
        • Hanusch Hospital, Department of Ophthalmology

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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cataract
  • Age 21 and older
  • Regular corneal astigmatism ≥ 1.5 D
  • written informed consent prior to surgery

Exclusion Criteria:

  • Relevant other ophthalmic diseases such as: pseudoexfoliation, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
  • High myopia (> 29 mm AL)
  • Irregular corneal astigmatism on corneal topography
  • In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: lying
after cataract lying for 1 hour
Other: catarct surgery with toric intra ocular lenses
rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation
OTHER: sitting, walkin
after cataract sitting or walking for 1 hour
Other: catarct surgery with toric intra ocular lenses
rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of toric IOL rotation between both groups (mean ≠ SD)
Time Frame: 1 Year
Aim is to see if the lying down after the operation lowers the risk of toric IOL rotation compared to sitting down
1 Year

Collaborators and Investigators

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

Sponsor

Prim. Prof. Dr. Oliver Findl, MBA

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)

February 1, 2021

Primary Completion (ANTICIPATED)

December 30, 2023

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (ACTUAL)

March 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 20-302-1220

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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