NCT03377075

Brief Summary

The aim of the study is the non-invasive morphological evaluation of the choroid and the retina in relation to the length of the eyeball in healthy, young man and women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

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

February 6, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

December 13, 2017

Last Update Submit

February 26, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Relation of choroidal thickness to axial length

    Through study completion, 6 months

  • Relation of retinal thickness to axial length

    Through study completion, 6 months

Secondary Outcomes (2)

  • Influence of age on results

    Through study completion, 6 months

  • Influence of gender on results

    Through study completion, 6 months

Study Arms (1)

Healthy subjects

Device: AL measurementDevice: OCT

Interventions

AL measurementDEVICE

IOL Master 500 (Carl Zeiss AG, Germany)

Healthy subjects
OCTDEVICE

Choroidal and retinal thickness measurement (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan)

Healthy subjects

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy subject with no eye diseases.

You may qualify if:

  • years of age or older, but less than 29 years of age
  • Caucasian race
  • Signed informed consent

You may not qualify if:

  • Known epilepsy
  • Inability to act
  • Media opacity in the eye that would disturb imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University, Department of Ophthalmology

Budapest, 1085, Hungary

Location

Study Officials

  • Miklos Schneider

    Semmelweis University, Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 19, 2017

Study Start

February 6, 2017

Primary Completion

October 3, 2018

Study Completion

November 30, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)