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

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ClinicalTrials.gov Identifier: NCT03419351
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Martin Leitritz, University Hospital Tuebingen

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.


Condition or disease Intervention/treatment Phase
Refractive Errors Self-Examination Diagnostic Test: Smartphone Diagnostic Test: Autorefractor Diagnostic Test: Individual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Main group
Main study group including all individuals that underwent the study procedures
Diagnostic Test: Smartphone
Smartphone based measurement of refractive error and visual acuity testing using these measurements.

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

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




Primary Outcome Measures :
  1. Refractive Error [ Time Frame: 6 month ]
    Comparison of refractive error measurements between methods


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 6 month ]
    Visual acuity of persons using based on different methods.

  2. Personal evaluation of measuring accuracy (Questionnaire) [ Time Frame: 6 month ]
    Would persons be willing to order glasses by using only self-test-results?

  3. Time consumption [ Time Frame: 6 month ]
    Comparison of needed time to reach self-test refraction error results and conservative-test results.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419351


Locations
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Germany
University Eye Hospital Recruiting
Tuebingen, BW, Germany, 72076
Contact: Martin A Leitritz, M.D.    +49 (0) 7071-29-88088    martin.leitritz@med.uni-tuebingen.de   
Principal Investigator: Martin A Leitritz, M.D.         
Sub-Investigator: Sebastian Mueller, M.D.         
Principal Investigator: Markus Schulze-Schwering, M.D.         
Sponsors and Collaborators
University Hospital Tuebingen

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Responsible Party: Dr. Martin Leitritz, Principal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03419351     History of Changes
Other Study ID Numbers: smart-glass
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases