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CompletedNCT03839888Updated Feb 15, 2019

Short Term Refractive and Ocular Parameter Changes After Topical Atropine

An interventional study of 0.125% Atropine in Myopia, Left Eye, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Completed. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Jan 2015, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Not applicable
Ages
3 Years to 18 Years
Sex
All
01

Study 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. Postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.

02

Conditions studied

  • Myopia, Left Eye

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Keywords

  • atropine
  • cycloplegia
  • refraction
  • axial length
  • anterior chamber depth
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 96 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 55 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who had an SER of -0.5 diopters or less in their eyes.

Exclusion criteria

Exclusion Criteria:

  • Patients who had already been undergoing cycloplegic treatment for myopia before.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    0.125% atropine group

    patients used the 0.125 % atropine eyedrop every night before sleep for 7 days

    Drug: 0.125% Atropine

Interventions

  • Drug0.125% Atropine

    patients used 0.125% atropine eyedrop per night before sleep for 7 days.

06

What researchers measure

Primary outcomes

  1. SER

    Spherical equivalent refractive error

    Time frame: change from SER at 7 days

Secondary outcomes

  1. AL

    Axial length

    Time frame: change from AL at 7 days

  2. ACD

    anterior chamber depth

    Time frame: change from ACD at 7 days

  3. IOP

    intraocular pressure

    Time frame: change from IOP at 7 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03839888
Lead sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Responsible party
Sponsor
First posted
Feb 15, 2019
Start date
Jan 1, 2015
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015
Last update
Feb 15, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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