NCT03402100

Brief Summary

The myopia prevalence in schoolchildren is high in Taiwan. The myopia progression is fast in children and often associated high myopia in later life. This prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 18, 2018

Status Verified

December 1, 2017

Enrollment Period

5.2 years

First QC Date

January 4, 2018

Last Update Submit

January 16, 2018

Conditions

Myopia, ProgressiveAtropine Allergy

Keywords

myopiaschoolchildrenatropineallergyeye dropsoutdoornear work

Outcome Measures

Primary Outcomes (2)

  • Cycloplegic spherical refraction change measured by auto-refractometer (Diopter)

    Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression.

    1 year

  • Axial length change (mm) measured by non-contact biometry

    Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression.

    1 year

Secondary Outcomes (5)

  • Intraocular pressure (mmHg) by non-contact tonometer

    1 year

  • Accommodation (diopter) by accommodometer

    1 year

  • Pupil size (mm) by electronic rule

    1 year

  • Anterior chamber depth (mm) measured by non-contact biometry

    1 year

  • Posterior chamber depth (mm) measured by non-contact biometry

    1 year

Other Outcomes (1)

  • Questionnaire

    1 year

Study Arms (5)

0.01% atropine

EXPERIMENTAL

children who received 0.01% atropine for myopia

Drug: eye drops

0.005% atropine

EXPERIMENTAL

children who received 0.005% atropine for myopia

Drug: eye drops

0.25% Ketorolac

EXPERIMENTAL

children who received 0.25% Ketorolac for myopia

Drug: eye drops

0.01% atropine plus 0.25% Ketorolac

EXPERIMENTAL

children who received 0.01% atropine plus 0.25% Ketorolac for myopia

Drug: eye drops

0.005% atropine plus 0.25% Ketorolac

EXPERIMENTAL

children who received 0.005% atropine plus 0.25% Ketorolac for myopia

Drug: eye drops

Interventions

eye dropsDRUG

children who received daily eye drops for myopia

0.005% atropine0.005% atropine plus 0.25% Ketorolac0.01% atropine0.01% atropine plus 0.25% Ketorolac0.25% Ketorolac

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Myopia diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
  • Must be able to use eye drops

You may not qualify if:

  • astigmatism -1.50 D or greater
  • strabismus
  • amblyopia
  • cataract
  • glaucoma
  • any ocular diseases ocular surgery
  • history of systemic diseases (ex. asthma, heart disease...)
  • contact lenses user
  • orthokeratology user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

MeSH Terms

Conditions

Myopia, DegenerativeMyopiaHypersensitivity

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Pei-Chang Wu, MD

    No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Chang Wu, MD

CONTACT

wooopc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 18, 2018

Study Start

October 20, 2014

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 18, 2018

Record last verified: 2017-12

Locations

TW(1)