Myopia,NCT01995435
Refraction Determination Analysis
A study testing Telemedicine refraction and Traditional refraction in people with Myopia, and Hyperopia,, run by Lee, Steven, M.D..
Trial summary
Correlating the accuracy of a refraction done over telemedicine to that of a standard refraction, with a study hypothesis that the results will be equivalent. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia,, Hyperopia,, Astigmatism,
- What is being tested?
- Telemedicine refraction and Traditional refraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jun 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years old
- healthy eyes
Who cannot join
- mid level ocular diseases (glaucoma, hypertension, retinal issues)
- psychiatric disorders
- brain tumor or history of
- under 18, or over 40 years old
About this study
Correlating the accuracy of a refraction done over telemedicine to that of a standard refraction, with a study hypothesis that the results will be equivalent.
- Conditions
- Myopia,, Hyperopia,, Astigmatism,, Presbyopia,, Eye Strain,
- Being tested
- Telemedicine refraction, Traditional refraction
- Medical subject headings
- Myopia, Hyperopia, Astigmatism, Presbyopia, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine refractionDevice
Also called Glasses,, Contact lenses,, Refractive surgery,
Traditional refractionDevice
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine refraction before traditional refraction | Experimental | We will first refract an individual using telemedicine refraction, and then refract them using a traditional refraction method. Receives: Device: Telemedicine refraction; Device: Traditional refraction |
| Traditional refraction before telemedicine refraction | Experimental | We will first refract an individual using a traditional refraction, and then refract them using a telemedicine refraction method. Receives: Device: Telemedicine refraction; Device: Traditional refraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
refraction in diopters over telemedicine compared standard phoropter refraction
Measured: an average of 1 year
Secondary outcomes (1)
telemedicine refraction results beyond dioptric readings
to see if there are other uses for telemedicine refraction results
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia,Studies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee, Steven, M.D.
- Responsible party
- Principal investigator, Coad Dow, MD, Chippewa Valley Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995435
- Sponsor's protocol ID
- SPL-321-REF
- Status last verified
- Sep 2015
- First submitted
- 12 Nov 2013
- Last updated
- 7 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refraction Determination Analysis
- ClinicalTrials.gov ID
- NCT01995435
- Acronym / sponsor ID
- SPL-321-REF
- Conditions
- Myopia,, Hyperopia,, Astigmatism,, Presbyopia,, Eye Strain,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lee, Steven, M.D.
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Nov 2013 (estimated)
- 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.
Correlating the accuracy of a refraction done over telemedicine to that of a standard refraction, with a study hypothesis that the results will be equivalent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine refraction before traditional refraction | Experimental | Device: Telemedicine refraction, Device: Traditional refractionWe will first refract an individual using telemedicine refraction, and then refract them using a traditional refraction method. |
| Traditional refraction before telemedicine refraction | Experimental | Device: Telemedicine refraction, Device: Traditional refractionWe will first refract an individual using a traditional refraction, and then refract them using a telemedicine refraction method. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-40 years old
- healthy eyes
Key exclusion criteria (4 listed)
- mid level ocular diseases (glaucoma, hypertension, retinal issues)
- psychiatric disorders
- brain tumor or history of
- under 18, or over 40 years old
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 |
|---|---|---|
| Telemedicine refractionAlso: Glasses,, Contact lenses,, Refractive surgery, | Device | Telemedicine refraction before traditional refraction, Traditional refraction before telemedicine refraction |
| Traditional refraction | Device | Telemedicine refraction before traditional refraction, Traditional refraction before telemedicine refraction |
Primary outcome
refraction in diopters over telemedicine compared standard phoropter refraction
Time frame: an average of 1 year
1 secondary outcome
telemedicine refraction results beyond dioptric readings
Time frame: an average of 1 year
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 7 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine refraction and Traditional refraction in people with Myopia, and Hyperopia,, run by Lee, Steven, M.D..
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: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
refraction in diopters over telemedicine compared standard phoropter refraction (time frame: an average of 1 year). 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 7 Sep 2015.