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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04776057
Other study ID # EK 20-302-1220
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date December 30, 2023

Study information

Verified date October 2022
Source Vienna Institute for Research in Ocular Surgery
Contact Julius Hienert, MD
Phone +436646415113
Email j.hienert@viros.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Hanusch Hospital, Department of Ophthalmology Vienna

Sponsors (1)

Lead Sponsor Collaborator
Prim. Prof. Dr. Oliver Findl, MBA

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of toric IOL rotation between both groups (mean ? SD) Aim is to see if the lying down after the operation lowers the risk of toric IOL rotation compared to sitting down 1 Year
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