NCT06667037

Brief Summary

The purpose of this multicenter randomized clinical trial is to evaluate the myopia control effect of orthokeratology and 0.01% atropine sequential treatment in children and adolescents, as compared to continuous treatment with orthokeratology.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Sep 2024Mar 2027

Study Start

First participant enrolled

September 21, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

October 14, 2024

Last Update Submit

February 25, 2025

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Axial length change

    Axial length change (mm) is characterized as the difference between 25-month follow-up visit and baseline values. The IOLMaster or Lenstar are used to measure axial length (mm).

    From baseline to the end of treatment at 25 months

Secondary Outcomes (3)

  • Proportion of rapid myopia progression

    From baseline to the end of treatment at 25 months

  • Axial length change

    From baseline to 3, 6, 9, 12, and 19 months.

  • Incidence of adverse events

    From baseline to 25 months.

Study Arms (2)

Ortho-k and 0.01% atropine sequential treatment

EXPERIMENTAL

Participants will be treated with ortho-k lenses during the first year, and swiched to recieve 0.01% atropine twice a day in the second year.

Device: Ortho-k lensesDrug: 0.01% Atropine

Ortho-k continuous treatment

ACTIVE COMPARATOR

Participants will be treated with ortho-k lenses throughout, during the 2-year study period.

Device: Ortho-k lenses

Interventions

Ortho-k lensesDEVICE

Ortho-k lenses will be administered nightly.

Ortho-k and 0.01% atropine sequential treatmentOrtho-k continuous treatment
0.01% AtropineDRUG

0.01% Atropine will be administrated twice a day with an interval of about 12 hours. Drop into the conjunctival sac and immediately compress the lacrimal sac of the inner canthus for 2-3 minutes.

Ortho-k and 0.01% atropine sequential treatment

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 8-15 years old.
  • Spherical equivalent refractions (SERs) -0.50 to -6.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D.
  • Best corrected visual acuity (BCVA) equal to or better than 20/25 in both eyes.
  • Bilateral intra-ocular pressure \< 21mmHg.
  • Normal binocular and stereoscopic visual function.
  • Participants and their guardians' understanding and acceptance of random allocation of grouping.

You may not qualify if:

  • Manifest strabismus, except for intermittent tropia.
  • Ocular or systemic diseases which may affect vision or refractive error.
  • Previous use of myopia control without washout, including atropine, myopia control spectacles, myopia control contact lenses.
  • Other contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Central Study Contacts

Yin Hu, Doctor

CONTACT

86-18664783831eddy06980094@163.com

Xiao Yang, Professor

CONTACT

86-13760766303yangx_zoc@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 31, 2024

Study Start

September 21, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)