Comparison of a Smartphone Based Self Refraction Tool Wit... | NCT03419351

Studies
Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods

NCT03419351

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Feb 1, 2018Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Refractive Errors
Self-Examination

Interventions

Smartphone
Autorefractor
Individual

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2017Actual

Primary Completion Date

Jan 31, 2018Estimated

Completion Date

Mar 31, 2018Estimated

First Submitted Date

Dec 6, 2017

First Submission Date that Met QC Criteria

Jan 31, 2018

First Posted Date

Feb 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2018

Last Update Posted Date

Feb 1, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Martin Leitritz, Principal Investigator, University Hospital TuebingenPrincipal Investigator

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Main group	Other	Main study group including all individuals that underwent the study procedures	Diagnostic Test: Smartphone Diagnostic Test: Autorefractor Diagnostic Test: Individual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Smartphone	Diagnostic Test	Smartphone based measurement of refractive error and visual acuity testing using these measurements.	Main group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Refractive Error	Comparison of refractive error measurements between methods	6 month

Secondary Outcomes

Measure	Description	Time Frame
Visual acuity	Visual acuity of persons using based on different methods.	6 month
Personal evaluation of measuring accuracy (Questionnaire)	Would persons be willing to order glasses by using only self-test-results?

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

existing refractive error
using glasses or contac lenses

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Hospital	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012030	Refractive Errors
D016353	Self-Examination

Ancestor Terms

ID	Term
D005128	Eye Diseases
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided