Refractive ErrorsNCT05049070
Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction
A study testing Mobile medical application to self administer a subjective refraction test in people with Refractive Errors, run by 1800 Contacts, Inc. at 12 sites in United States.
Trial summary
This study evaluates the reliability, validity and safety of a self administered, subjective refraction test via a mobile medical app (GoEyes) as compared to standard of care subjective manifest refraction performed by a health care provider, in subjects who have no known ocular disease or condition other than… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Mobile medical application to self administer a subjective refraction test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 12 sitesUnited States
- Study dates
- 15 Sep 2021to Jun 2023
- 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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females aged 18-39 years who currently wear glasses and/or soft contact lenses to correct refractive error
- Normal color vision
- Able to use both hands at the same time and to hear, understand and verbally respond to audio instructions
- Have single vision lenses only
- Able to provide informed consent -
Who cannot join
- Have any ongoing disease or ocular condition other than refractive error
- Have a history of permanent vison loss
- Have a neurological condition affecting vision
- Have worn glasses since age 6 or younger
- Have a prism in their prescription
- Use Rigid gas permeable lenses or OrthoK lenses
- Have had laser refractive surgery or any other eye surgery
- Use prescription eye drops -
Trial locations and contacts
12 sites in 1 country.
Karen Howse contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Athens Eye Care
Athens, Ohio, 45701
Brendon Quarnberg
- Not yet recruiting
Matrix Clinical Research
Beverly Hills, California, 90210
Brendon Quarnberg
- Recruiting
Segal Drug Trials
Delray Beach, Florida, 33484
Brendon Quarnberg
- Not yet recruiting
Tauber Eye Center
Kansas City, Missouri, 64111
Brendon Quarnberg
- Not yet recruiting
IMA Research
Las Vegas, Nevada, 89102
Brendon Quarnberg
- Not yet recruiting
Butchertown Clinical Trials
Louisville, Kentucky, 40206
Brendon Quarnberg
- Recruiting
Optimed Research
Marysville, Ohio, 43040
Brendon Quarnberg
- Recruiting
Total Eye Care
Memphis, Tennessee, 38119
Brendon Quarnberg
- Not yet recruiting
Wagner Macula & Retina
Norfolk, Virginia, 23454
Brendon Quarnberg
- Not yet recruiting
North Bay Eye Associates
Petaluma, California, 94954
Brendon Quarnberg
- Not yet recruiting
Empire Clinical Research
Pomona, California, 91767
Brendon Quarnberg
- Not yet recruiting
Core, Inc Vita Eye Clinic
Shelby, North Carolina, 28150
Brendon Quarnberg
About this study
Official title: A Prospective, Multicenter, Open Label Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction Assessed by GoEyes
This study evaluates the reliability, validity and safety of a self administered, subjective refraction test via a mobile medical app (GoEyes) as compared to standard of care subjective manifest refraction performed by a health care provider, in subjects who have no known ocular disease or condition other than refractive error.
Read the detailed description
GoEyes is a Mobile Medical Application, which can be downloaded to a smartphone and is being developed as a self -administered subjective refraction examination that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals.
The Study will be conducted in 2 parts; Part 1 and Part 2.
Approximately 59 participants will be enrolled In Part 1. Part 1 participants will have a GoEyes refraction test in clinic on two separate days and will also have a standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.
Approximately 349 participants will be enrolled in Part 2. Part 2 participants will self administer the GoEyes test at home on 2 separate days and will also have in clinic standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.
- Conditions
- Refractive Errors
- Being tested
- Mobile medical application to self administer a subjective refraction test, Standard of care refraction test
- Keywords
- Refractive Errors, Myopia, Mobile Applications
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile medical application to self administer a subjective refraction testDiagnostic test
Also called GoEyes
GoEyes is a software as a medical device and mobile medical application, which is downloaded to a smartphone and is a self-administered subjective refraction test that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals
Standard of care refraction testDiagnostic test
Standard of care subjective manifest refraction test performed by a healthcare professional
| Study group | Role | What they receive |
|---|---|---|
| GoEyes | Experimental | GoEyes Self administered refraction test + Standard of care refraction test Receives: Diagnostic Test: Mobile medical application to self administer a subjective refraction test; Diagnostic Test: Standard of care refraction test |
What is being measured
The primary outcome is the main question the study is designed to answer.
90% Concordance for sphere power and cylinder power (monocular)
Measured: Baseline
Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power
Measured: Baseline
Monocular refractive outcomes
Lower confidence limit of ≥ 90% for concordance (for right and left eyes separately)
Measured: Baseline
Monocular visual acuity
Lower confidence limit of ≥95% (for right and left eyes combined)
Measured: Baseline
Proportion of out-of-range eye that are correctly excluded
Measured: Baseline
Incidence of Adverse Events in Part 1
Measured: 21 days
Incidence of Adverse Events in Part 2
Measured: 8 Days
Secondary outcomes (7)
Descriptive statistics for sphere power and cylinder power (monocular)
Measured: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Descriptive statistics for cylinder axis (monocular) stratified by cylinder power
Measured: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Descriptive statistics for concordance of monocular refractive outcomes (for right and left eyes separately
Measured: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined
Measured: Baseline
Proportion of out of range eyes that are correctly excluded
Measured: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Comparison of test and re-test measurements to Standard of Care (SOC) data
Measured: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Rate of disagreement between GoEyes screening at home and in-clinic screening
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start15 Sep 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (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
- 349 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 1800 Contacts, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049070
- Sponsor's protocol ID
- QAD-079
- Status last verified
- Apr 2023
- First submitted
- 23 Aug 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open Label Study to Evaluate the Reliability, Validity and Safety of Subjective Mobile Refraction Assessed by GoEyes
- ClinicalTrials.gov ID
- NCT05049070
- Acronym / sponsor ID
- QAD-079
- Conditions
- Refractive Errors
- Keywords
- Refractive Errors, Myopia, Mobile Applications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 349 participants (estimated)
- Lead sponsor
- 1800 Contacts, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 17 Sep 2021 (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.
This study evaluates the reliability, validity and safety of a self administered, subjective refraction test via a mobile medical app (GoEyes) as compared to standard of care subjective manifest refraction performed by a health care provider, in subjects who have no known ocular disease or condition other than refractive error.
Detailed description
GoEyes is a Mobile Medical Application, which can be downloaded to a smartphone and is being developed as a self -administered subjective refraction examination that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals.
The Study will be conducted in 2 parts; Part 1 and Part 2.
Approximately 59 participants will be enrolled In Part 1. Part 1 participants will have a GoEyes refraction test in clinic on two separate days and will also have a standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.
Approximately 349 participants will be enrolled in Part 2. Part 2 participants will self administer the GoEyes test at home on 2 separate days and will also have in clinic standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GoEyes | Experimental | Diagnostic Test: Mobile medical application to self administer a subjective refraction test, Diagnostic Test: Standard of care refraction testGoEyes Self administered refraction test + Standard of care refraction test |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females aged 18-39 years who currently wear glasses and/or soft contact lenses to correct refractive error
- Normal color vision
- Able to use both hands at the same time and to hear, understand and verbally respond to audio instructions
- Have single vision lenses only
- Able to provide informed consent -
Key exclusion criteria (8 listed)
- Have any ongoing disease or ocular condition other than refractive error
- Have a history of permanent vison loss
- Have a neurological condition affecting vision
- Have worn glasses since age 6 or younger
- Have a prism in their prescription
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 |
|---|---|---|
| Mobile medical application to self administer a subjective refraction testAlso: GoEyesGoEyes is a software as a medical device and mobile medical application, which is downloaded to a smartphone and is a self-administered subjective refraction test that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals | Diagnostic test | GoEyes |
| Standard of care refraction testStandard of care subjective manifest refraction test performed by a healthcare professional | Diagnostic test | GoEyes |
Primary outcome
90% Concordance for sphere power and cylinder power (monocular)
Time frame: Baseline
Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power
Time frame: Baseline
Monocular refractive outcomes
Time frame: Baseline
Lower confidence limit of ≥ 90% for concordance (for right and left eyes separately)
Monocular visual acuity
Time frame: Baseline
Lower confidence limit of ≥95% (for right and left eyes combined)
Proportion of out-of-range eye that are correctly excluded
Time frame: Baseline
Incidence of Adverse Events in Part 1
Time frame: 21 days
Incidence of Adverse Events in Part 2
Time frame: 8 Days
7 secondary outcomes
Descriptive statistics for sphere power and cylinder power (monocular)
Time frame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Descriptive statistics for cylinder axis (monocular) stratified by cylinder power
Time frame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Descriptive statistics for concordance of monocular refractive outcomes (for right and left eyes separately
Time frame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined
Time frame: Baseline
Proportion of out of range eyes that are correctly excluded
Time frame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Comparison of test and re-test measurements to Standard of Care (SOC) data
Time frame: Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2)
Rate of disagreement between GoEyes screening at home and in-clinic screening
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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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.
Karen Howse contact
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile medical application to self administer a subjective refraction test in people with Refractive Errors, run by 1800 Contacts, Inc. at 12 sites in United States.
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 5 inclusion and 8 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
Contact Karen Howse (khowse@luna.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90% Concordance for sphere power and cylinder power (monocular) (time frame: Baseline). The study lists 7 primary outcomes in all. 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 6 Apr 2023.