Myopia, Left EyeNCT03839888
Short Term Refractive and Ocular Parameter Changes After Topical Atropine
A study testing 0.125% Atropine in people with Myopia, Left Eye, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Trial summary
In order we had designed a prospective clinical trial. Spherical equivalent refractive error (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125% atropine. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Myopia, Left Eye
- What is being tested?
- 0.125% Atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who had an SER of -0.5 diopters or less in their eyes.
Who cannot join
- Patients who had already been undergoing cycloplegic treatment for myopia before.
About this study
In order we had designed a prospective clinical trial. Spherical equivalent refractive error (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125% atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.
- Conditions
- Myopia, Left Eye
- Being tested
- 0.125% Atropine
- Keywords
- atropine, cycloplegia, refraction, axial length, anterior chamber depth
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.125% AtropineDrug
patients used 0.125% atropine eyedrop per night before sleep for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 0.125% atropine group | Experimental | patients used the 0.125 % atropine eyedrop every night before sleep for 7 days Receives: Drug: 0.125% Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
SER
Spherical equivalent refractive error
Measured: change from SER at 7 days
Secondary outcomes (3)
AL
Axial length
Measured: change from AL at 7 days
ACD
anterior chamber depth
Measured: change from ACD at 7 days
IOP
intraocular pressure
Measured: change from IOP at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2015
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myopia, Left EyeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839888
- Sponsor's protocol ID
- BuddhistTCGHTaipei2
- Status last verified
- Feb 2019
- First submitted
- 10 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ho MC, Hsieh YT, Shen EP, Hsu WC, Cheng HC. Short-term refractive and ocular parameter changes after topical atropine. Taiwan J Ophthalmol. 2019 Feb 20;10(2):111-115. doi: 10.4103/tjo.tjo_110_18. eCollection 2020 Apr-Jun.
PubMed 32874839
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Refractive and Ocular Parameter Changes After Topical Atropine
- ClinicalTrials.gov ID
- NCT03839888
- Acronym / sponsor ID
- BuddhistTCGHTaipei2
- Conditions
- Myopia, Left Eye
- Keywords
- atropine, cycloplegia, refraction, axial length, anterior chamber depth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 15 Feb 2019 (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.
In order we had designed a prospective clinical trial. Spherical equivalent refractive error (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125% atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.125% atropine group | Experimental | Drug: 0.125% Atropinepatients used the 0.125 % atropine eyedrop every night before sleep for 7 days |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who had an SER of -0.5 diopters or less in their eyes.
Key exclusion criteria (1 listed)
- Patients who had already been undergoing cycloplegic treatment for myopia before.
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 |
|---|---|---|
| 0.125% Atropinepatients used 0.125% atropine eyedrop per night before sleep for 7 days. | Drug | 0.125% atropine group |
Primary outcome
SER
Time frame: change from SER at 7 days
Spherical equivalent refractive error
3 secondary outcomes
AL
Time frame: change from AL at 7 days
ACD
Time frame: change from ACD at 7 days
IOP
Time frame: change from IOP at 7 days
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 15 Feb 2019.
- Derived from this study: PubMed 32874839Ho MC, Hsieh YT, Shen EP, Hsu WC, Cheng HC. Short-term refractive and ocular parameter changes after topical atropine. Taiwan J Ophthalmol. 2019 Feb 20;10(2):111-115. doi: 10.4103/tjo.tjo_110_18. eCollection 2020 Apr-Jun.
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 0.125% Atropine in people with Myopia, Left Eye, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
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 1 inclusion and 1 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 15 Feb 2019. 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?
SER (time frame: change from SER at 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839888, which also lists 1 linked publication.
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 15 Feb 2019; AzTrials last refreshed its copy on 29 Oct 2026.