NCT03419351

Brief Summary

Self evaluating tools based on smartphone devices are public available on the market for each person. The tools are used to estimate the existing refractive error for each eye of a patient. Hereafter, e.g. ordering glasses via internet could be the next step for this persons. The daily routine within an eye hospital shows, that estimation of the refractive error is a difficult and time consuming procedure. The study compares the results of the measured refractive error using a smartphone based tool with the results of conventional measurement methods.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

December 6, 2017

Last Update Submit

January 31, 2018

Conditions

Refractive ErrorsSelf-Examination

Outcome Measures

Primary Outcomes (1)

  • Refractive Error

    Comparison of refractive error measurements between methods

    6 month

Secondary Outcomes (3)

  • Visual acuity

    6 month

  • Personal evaluation of measuring accuracy (Questionnaire)

    6 month

  • Time consumption

    6 month

Study Arms (1)

Main group

OTHER

Main study group including all individuals that underwent the study procedures

Diagnostic Test: SmartphoneDiagnostic Test: AutorefractorDiagnostic Test: Individual

Interventions

SmartphoneDIAGNOSTIC_TEST

Smartphone based measurement of refractive error and visual acuity testing using these measurements.

Main group
AutorefractorDIAGNOSTIC_TEST

Autorefractor based measurement of refractive error and visual acuity testing using these measurements.

Main group
IndividualDIAGNOSTIC_TEST

Individual, human measurement of refractive error and visual acuity testing using these measurements.

Main group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • existing refractive error
  • using glasses or contac lenses

You may not qualify if:

  • opacities (visus limitating) of cornea, lens or vitreous
  • known ocular pathologies except refractive error
  • epilepsia
  • irregular corneal topography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Refractive ErrorsSelf-Examination

Condition Hierarchy (Ancestors)

Eye DiseasesHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2017

First Posted

February 1, 2018

Study Start

November 20, 2017

Primary Completion

January 31, 2018

Study Completion

March 31, 2018

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

DE(1)