Short Term Refractive and Ocular Parameter Changes After... | NCT03839888

Studies
Short Term Refractive and Ocular Parameter Changes After Topical Atropine

NCT03839888

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Status

Completed

Last Update Posted

Feb 15, 2019Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Myopia, Left Eye

Interventions

0.125% Atropine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Feb 10, 2019

First Submission Date that Met QC Criteria

Feb 11, 2019

First Posted Date

Feb 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2019

Last Update Posted Date

Feb 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.125% atropine group	Experimental	patients used the 0.125 % atropine eyedrop every night before sleep for 7 days	Drug: 0.125% Atropine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.125% Atropine	Drug	patients used 0.125% atropine eyedrop per night before sleep for 7 days.	0.125% atropine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SER	Spherical equivalent refractive error	change from SER at 7 days

Secondary Outcomes

Measure	Description	Time Frame
AL	Axial length	change from AL at 7 days
ACD	anterior chamber depth	change from ACD at 7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32874839	Derived	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.

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds