MyopiaNCT03502863
Clinical Study to Evaluate Effectiveness of Digital Refraction
A study testing Digital refraction and Manual Refraction in people with Myopia and Astigmatism, run by Visibly at 3 sites in United States.
Trial summary
Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Digital refraction and Manual Refraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Apr 2018to 6 Jul 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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be between 22 and 55 years of age at the time of consent.
- Subject must have a refractive error
- With no greater than -3.00 D myopia and -2.00 D astigmatism in either eye.
- With prior correction of no greater than -10.00 D myopia and requiring over-refraction of no more than 2.75 D in either eye.
- 5. Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better.
Who cannot join
- Subjects with diabetes mellitus.
- Subjects using ophthalmic or systemic corticosteroids.
- Subjects with autoimmune conditions.
- Subjects with active corneal or conjunctival infection.
- Subjects with active corneal, conjunctival, or intraocular inflammation (ie, uveitis).
- Subjects with diabetic retinopathy.
Show all 12Show fewer
- Subjects with glaucoma or ocular hypertension.
- Subjects with macular degeneration.
- Subjects with previous ocular surgery.
- Subjects on antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex).
- Pregnancy
- Subjects who, in the judgment of the Investigator, may be inappropriate for the intended study procedures.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site 03
Fort Lauderdale, Florida, 33324
Site 01
Harlingen, Texas, 78550
Site 02
Nashville, Tennessee, 37215
About this study
Official title: A Prospective Clinical Study to Evaluate the Effectiveness of Digital Refraction
Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.
Read the detailed description
A digital refraction tool is a device meant to measure visual acuity and to subjectively measure refractive value for a patient's eye for the conditions of myopia and astigmatism. It is intended for adults aged 22 to 55 years that have no prior correction with up to 3.00 diopters (D) of myopia and up to 2.00 D of astigmatism, or those with prior correction up to 10.00 D of myopia and require an over-refraction of no more than 2.75 D.
LogMAR (ETDRS) chart to measure visual acuity.
The manual manifest refraction is performed by an eyecare specialist using a phoropter.
The LogMAR Visual Acuity chart is used to measure visual acuity. The manual refraction will be used in this study for obtaining the refractive error of each eye.
- Conditions
- Myopia, Astigmatism
- Being tested
- Digital refraction, Manual Refraction
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital refractionDevice
A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone.
Manual RefractionOther
Manual refraction and ETDRS chart
| Study group | Role | What they receive |
|---|---|---|
| Digital refraction | Experimental | Web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone Receives: Other: Manual Refraction |
| Manual Refraction | Active comparator | Manual manifest refraction is performed by an eyesore specialist using a phoropter. Receives: Device: Digital refraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
A digital refraction will be compared to standard manual refraction methods (using a phoropter) to the correlation of the two methods.
The difference between testing methods (Manual Refraction with a phoropter versus a digital refraction test) will be analyzed by mean, standard deviation, and 95% confidence interval overall and by the levels of refractive correction (sphere, cylinder, MRSE) and for visual acuity using LogMAR format.
Measured: After the Day 1 Visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start19 Apr 2018
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visibly
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S Lee, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502863
- Sponsor's protocol ID
- OPT-1001
- Status last verified
- Oct 2018
- First submitted
- 7 Apr 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study to Evaluate the Effectiveness of Digital Refraction
- ClinicalTrials.gov ID
- NCT03502863
- Acronym / sponsor ID
- OPT-1001
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- VisiblyIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 19 Apr 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.
Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.
Detailed description
A digital refraction tool is a device meant to measure visual acuity and to subjectively measure refractive value for a patient's eye for the conditions of myopia and astigmatism. It is intended for adults aged 22 to 55 years that have no prior correction with up to 3.00 diopters (D) of myopia and up to 2.00 D of astigmatism, or those with prior correction up to 10.00 D of myopia and require an over-refraction of no more than 2.75 D.
LogMAR (ETDRS) chart to measure visual acuity.
The manual manifest refraction is performed by an eyecare specialist using a phoropter.
The LogMAR Visual Acuity chart is used to measure visual acuity. The manual refraction will be used in this study for obtaining the refractive error of each eye.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital refraction | Experimental | Other: Manual RefractionWeb-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone |
| Manual Refraction | Active comparator | Device: Digital refractionManual manifest refraction is performed by an eyesore specialist using a phoropter. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject must be between 22 and 55 years of age at the time of consent.
- Subject must have a refractive error
- 5. Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better.
Key exclusion criteria (12 listed)
- Subjects with diabetes mellitus.
- Subjects using ophthalmic or systemic corticosteroids.
- Subjects with autoimmune conditions.
- Subjects with active corneal or conjunctival infection.
- Subjects with active corneal, conjunctival, or intraocular inflammation (ie, uveitis).
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 |
|---|---|---|
| Digital refractionA web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone. | Device | Manual Refraction |
| Manual RefractionManual refraction and ETDRS chart | Other | Digital refraction |
Primary outcome
A digital refraction will be compared to standard manual refraction methods (using a phoropter) to the correlation of the two methods.
Time frame: After the Day 1 Visits
The difference between testing methods (Manual Refraction with a phoropter versus a digital refraction test) will be analyzed by mean, standard deviation, and 95% confidence interval overall and by the levels of refractive correction (sphere, cylinder, MRSE) and for visual acuity using LogMAR format.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
S Lee study director
Sponsor GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital refraction and Manual Refraction in people with Myopia and Astigmatism, run by Visibly at 3 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 12 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: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A digital refraction will be compared to standard manual refraction methods (using a phoropter) to the correlation of the two methods. (time frame: After the Day 1 Visits). 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 26 Oct 2018.