Refractive ErrorsNCT03419351
Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
A study testing Smartphone, Autorefractor and Individual in people with Refractive Errors and Self-Examination, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Self-Examination
- What is being tested?
- Smartphone, Autorefractor and Individual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- existing refractive error
- using glasses or contac lenses
Who cannot join
- opacities (visus limitating) of cornea, lens or vitreous
- known ocular pathologies except refractive error
- epilepsia
- irregular corneal topography
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Eye Hospital
Tübingen, Baden-Wurttemberg, 72076
Martin A Leitritz, M.D., +49 (0) 7071-29-88088, martin.leitritz@med.uni-tuebingen.de
Martin A Leitritz, M.D.
About this study
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.
- Conditions
- Refractive Errors, Self-Examination
- Being tested
- Smartphone, Autorefractor, Individual
- Medical subject headings
- Refractive Errors, Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartphoneDiagnostic test
Smartphone based measurement of refractive error and visual acuity testing using these measurements.
AutorefractorDiagnostic test
Autorefractor based measurement of refractive error and visual acuity testing using these measurements.
IndividualDiagnostic test
Individual, human measurement of refractive error and visual acuity testing using these measurements.
| Study group | Role | What they receive |
|---|---|---|
| Main group | Other | Main study group including all individuals that underwent the study procedures Receives: Diagnostic Test: Smartphone; Diagnostic Test: Autorefractor; Diagnostic Test: Individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive Error
Comparison of refractive error measurements between methods
Measured: 6 month
Secondary outcomes (3)
Visual acuity
Visual acuity of persons using based on different methods.
Measured: 6 month
Personal evaluation of measuring accuracy (Questionnaire)
Would persons be willing to order glasses by using only self-test-results?
Measured: 6 month
Time consumption
Comparison of needed time to reach self-test refraction error results and conservative-test results.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start20 Nov 2017
- Primary completion31 Jan 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin Leitritz, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419351
- Sponsor's protocol ID
- smart-glass
- Status last verified
- Jan 2018
- First submitted
- 6 Dec 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
- ClinicalTrials.gov ID
- NCT03419351
- Acronym / sponsor ID
- smart-glass
- Conditions
- Refractive Errors, Self-Examination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main group | Other | Diagnostic Test: Smartphone, Diagnostic Test: Autorefractor, Diagnostic Test: IndividualMain study group including all individuals that underwent the study procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- existing refractive error
- using glasses or contac lenses
Key exclusion criteria (4 listed)
- opacities (visus limitating) of cornea, lens or vitreous
- known ocular pathologies except refractive error
- epilepsia
- irregular corneal topography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartphoneSmartphone based measurement of refractive error and visual acuity testing using these measurements. | Diagnostic test | Main group |
| AutorefractorAutorefractor based measurement of refractive error and visual acuity testing using these measurements. | Diagnostic test | Main group |
| IndividualIndividual, human measurement of refractive error and visual acuity testing using these measurements. | Diagnostic test | Main group |
Primary outcome
Refractive Error
Time frame: 6 month
Comparison of refractive error measurements between methods
3 secondary outcomes
Visual acuity
Time frame: 6 month
Personal evaluation of measuring accuracy (Questionnaire)
Time frame: 6 month
Time consumption
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone, Autorefractor and Individual in people with Refractive Errors and Self-Examination, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive Error (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018; AzTrials last refreshed its copy on 30 Oct 2026.