NCT02155556

Brief Summary

Aim of this study is to gain a better understanding of the diurnal changes of the cornea to improve toric IOL power calculations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

June 2, 2014

Last Update Submit

March 13, 2020

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • Descriptive analysis of diurnal changes of the corneal radii (in diopters) and orientation of the steep meridian (in degrees) in young healthy subjects and elderly patients

    24 hours

Secondary Outcomes (1)

  • Comparison of the corneal radii (in diopters) and orientation of the steep meridian (in degrees) between different measuring devices

    24 hours

Study Arms (1)

Healthy volunteers

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

20 volunteers/patients (10 patients \>50 years old; 5 patients with a corneal astigmatism of \>1 D)

You may qualify if:

  • years, or above
  • Signed informed consent

You may not qualify if:

  • Ophthalmic diseases such as significant macular degeneration, glaucoma, diabetic retinopathy, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Oliver Findl, MD, MBA

    VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, MBA

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 4, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 16, 2020

Record last verified: 2020-03

Locations

AU(1)