Back to resultsRotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation
Primary Purpose
Astigmatism
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
catarct surgery with toric intra ocular lenses
Sponsored by
About this trial
This is an interventional treatment trial for Astigmatism
Eligibility Criteria
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)
Sites / Locations
- Hanusch Hospital, Department of OphthalmologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
lying
sitting, walkin
Arm Description
after cataract lying for 1 hour
after cataract sitting or walking for 1 hour
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04776057
First Posted
February 25, 2021
Last Updated
October 12, 2022
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT04776057
Brief Title
Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation
Official Title
Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.
Detailed Description
To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lying
Arm Type
Other
Arm Description
after cataract lying for 1 hour
Arm Title
sitting, walkin
Arm Type
Other
Arm Description
after cataract sitting or walking for 1 hour
Intervention Type
Other
Intervention Name(s)
catarct surgery with toric intra ocular lenses
Intervention Description
rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation
Primary Outcome Measure Information:
Title
Comparison of toric IOL rotation between both groups (mean ≠ SD)
Description
Aim is to see if the lying down after the operation lowers the risk of toric IOL rotation compared to sitting down
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julius Hienert, MD
Phone
+436646415113
Email
j.hienert@viros.at
Facility Information:
Facility Name
Hanusch Hospital, Department of Ophthalmology
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof. MD
Phone
+43 1 91021 57564
Email
office@viros.at
12. IPD Sharing Statement
Learn more about this trial
Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation
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