MyopiaNCT03374306
Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate
A study testing Atropine (0.01%) and Artificial tear in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine (0.01%) and Artificial tear
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 7 and 10 years
- Good general health and no family history of ocular diseases
- No current or history of epilepsy or asthma
- Myopia : -0.50 to -1.00 D (inclusive, both eyes)
- Astigmatism : ≤ 0.50 D
- No hyperopia, amblyopia or strabismus
- No reported ocular eye diseases or disorders
- No drug allergy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Optometry, Hong Kong Polytechnic University
Hong Kong, 00000
About this study
Official title: Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses
Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.
- Conditions
- Myopia
- Being tested
- Atropine (0.01%), Artificial tear
- Keywords
- Myopia, Myopia control, Atropine, Electroretinogram, Multifocal Electroretinogram
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine (0.01%)Drug
tropical application
Artificial tearDrug
tropical application
| Study group | Role | What they receive |
|---|---|---|
| Atropine 0.01% | Experimental | Group receiving atropine treatment for 18 months Receives: Drug: Atropine (0.01%) |
| Artifical tear | Placebo comparator | Group receiving placebo for 18 months Receives: Drug: Artificial tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Changes in Refractive Error (SER)
Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months
Measured: 18 months
Secondary outcomes (1)
Annualized Change in Axial Length
Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Feb 2018
- Primary completion31 Dec 2019
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Henry HL Chan, PhD, The Hong Kong Polytechnic University
- Investigators
- Henry HL CHAN, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374306
- Sponsor's protocol ID
- HongKongPU_Optometry1
- Status last verified
- Oct 2024
- First submitted
- 11 Dec 2017
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses
- ClinicalTrials.gov ID
- NCT03374306
- Acronym / sponsor ID
- HongKongPU_Optometry1
- Conditions
- Myopia
- Keywords
- Myopia, Myopia control, Atropine, Electroretinogram, Multifocal Electroretinogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Atropine 0.01% | Experimental | Drug: Atropine (0.01%)Group receiving atropine treatment for 18 months |
| Artifical tear | Placebo comparator | Drug: Artificial tearGroup receiving placebo for 18 months |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age between 7 and 10 years
- Good general health and no family history of ocular diseases
- No current or history of epilepsy or asthma
- Myopia : -0.50 to -1.00 D (inclusive, both eyes)
- Astigmatism : ≤ 0.50 D
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Atropine (0.01%)tropical application | Drug | Atropine 0.01% |
| Artificial teartropical application | Drug | Artifical tear |
Primary outcome
Annualized Changes in Refractive Error (SER)
Time frame: 18 months
Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months
1 secondary outcome
Annualized Change in Axial Length
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Henry HL CHAN, PhD principal investigator
The Hong Kong Polytechnic 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 Atropine (0.01%) and Artificial tear in people with Myopia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 8 inclusion and 0 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 16 Oct 2024. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Annualized Changes in Refractive Error (SER) (time frame: 18 months). 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 16 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.