Refractive ErrorsNCT03615612
Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
A study testing QuickSee refractive error assessment + glasses in people with Refractive Errors, run by Johns Hopkins University at 1 site in India.
Trial summary
At the Aravind Eye Hospital (AEH) in Madurai, India, patients ages 18-40 receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and objective refraction, by way of the QuickSee autorefractor. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- QuickSee refractive error assessment + glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIndia
- Study dates
- 15 Dec 2017to 30 Aug 2019
- 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
- who visit a Vision Center for their eye check-up
- who are aged between 18 years and 40 years
Who cannot join
- whose refractive error is not within the detection range of the QuickSee device: -10 to +10 D
- who have a cylindrical power greater than 3 D
- who have to travel long distances (beyond 10kms) to the hospital
- who choose to buy spectacles that are priced more than Rs. 2000/- per pair
- who have speech or hearing impairment
- who do not speak the local language, Tamil
- who do not want to purchase spectacles from AEH
Trial locations and contacts
1 site in 1 country.
About this study
At the Aravind Eye Hospital (AEH) in Madurai, India, patients ages 18-40 receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and objective refraction, by way of the QuickSee autorefractor. Patients will then be randomized into one of two treatment plans: receive glasses from objective measure first then subjective measure second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a double blind, case-crossover clinical trial.
- Conditions
- Refractive Errors
- Being tested
- QuickSee refractive error assessment + glasses
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuickSee refractive error assessment + glassesOther
QuickSee refractive error assessment + glasses
| Study group | Role | What they receive |
|---|---|---|
| OR Eyeglasses, then SR | Other | Objective Refraction (OR) Eyeglasses, then Subjective Refraction (SR) Receives: Other: QuickSee refractive error assessment + glasses |
| SR Eyeglasses, then OR | Other | Subjective Refraction (SR) Eyeglasses, then Objective Refraction (OR) Receives: Other: QuickSee refractive error assessment + glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference
Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start15 Dec 2017
- Primary completion2 Aug 2019
- Study completion30 Aug 2019
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.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- PlenOptika, Inc., Aravind Eye Care System
- Responsible party
- Sponsor
- Investigators
- David Friedman, MD, MPH, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615612
- Sponsor's protocol ID
- IRB00157754
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2018
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Accuracy of a Low-cost, Portable, Autorefractor to Provide Well-tolerated Eyeglass Prescriptions
- ClinicalTrials.gov ID
- NCT03615612
- Acronym / sponsor ID
- IRB00157754
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- PlenOptika, Inc., Aravind Eye Care System
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 6 Aug 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.
At the Aravind Eye Hospital (AEH) in Madurai, India, patients ages 18-40 receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and objective refraction, by way of the QuickSee autorefractor. Patients will then be randomized into one of two treatment plans: receive glasses from objective measure first then subjective measure second, and vice versa. After one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. After a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. Patients may then decide which pair patient like best. This is a double blind, case-crossover clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OR Eyeglasses, then SR | Other | Other: QuickSee refractive error assessment + glassesObjective Refraction (OR) Eyeglasses, then Subjective Refraction (SR) |
| SR Eyeglasses, then OR | Other | Other: QuickSee refractive error assessment + glassesSubjective Refraction (SR) Eyeglasses, then Objective Refraction (OR) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- who visit a Vision Center for their eye check-up
- who are aged between 18 years and 40 years
Key exclusion criteria (7 listed)
- whose refractive error is not within the detection range of the QuickSee device: -10 to +10 D
- who have a cylindrical power greater than 3 D
- who have to travel long distances (beyond 10kms) to the hospital
- who choose to buy spectacles that are priced more than Rs. 2000/- per pair
- who have speech or hearing impairment
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 |
|---|---|---|
| QuickSee refractive error assessment + glassesQuickSee refractive error assessment + glasses | Other | OR Eyeglasses, then SR, SR Eyeglasses, then OR |
Primary outcome
Patient Preference
Time frame: 2 years
Patients are asked the question "Which eyeglasses did you prefer?". Patient response is then recorded.
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 21 Jul 2020.
- Individual participant dataSharing planned: Yes
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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.
David Friedman, MD, MPH, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuickSee refractive error assessment + glasses in people with Refractive Errors, run by Johns Hopkins University at 1 site in India.
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 7 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 21 Jul 2020. 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 India. 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?
Patient Preference (time frame: 2 years). 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 21 Jul 2020.