NCT04776057

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

February 25, 2021

Last Update Submit

October 12, 2022

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

lying

OTHER

after cataract lying for 1 hour

Other: catarct surgery with toric intra ocular lenses

sitting, walkin

OTHER

after cataract sitting or walking for 1 hour

Other: catarct surgery with toric intra ocular lenses

Interventions

catarct surgery with toric intra ocular lensesOTHER

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

lyingsitting, walkin

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanusch Hospital, Department of Ophthalmology

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Julius Hienert, MD

CONTACT

+436646415113j.hienert@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof Oliver Findl

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

February 1, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

AU(1)