NCT03516357

Brief Summary

Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

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

January 11, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2022

Completed
Last Updated

May 4, 2018

Status Verified

November 1, 2017

Enrollment Period

4 years

First QC Date

April 12, 2018

Last Update Submit

April 23, 2018

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • axial length measured by IOL-master

    measured by IOL-master

    2 years

Secondary Outcomes (10)

  • accommodation measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)

    2 years

  • peripheral refraction measured by open field auto ref/keratometer measurements(WAM-5500,Grand Seiko)

    2 years

  • IOP measured by Corvis-ST

    2 years

  • corneal thickness measured by Corvis-ST

    2 years

  • corneal biomechanical parameters measured by Corvis-ST

    2 years

  • +5 more secondary outcomes

Study Arms (3)

low myopia

-3.00D \< spherical equivalent refractive error \< -0.50D

moderate myopia

-6.00D \< spherical equivalent refractive error ≤ -3.0D

high myopia

spherical equivalent refractive error ≤ -6.0D

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

myopia

You may qualify if:

  • \. subjects were 6-16 years of age; 2.had no other ocular diseases aside from refractive error and no keratoconus (confirmed by pre-treatment corneal topography); 3. had an intraocular pressure (IOP) of \<21 mmHg; 4. had an with-the- rule astigmatism (axes 180 ± 30) ≤ 1.50 D; 5.had a best corrected visual acuity（BCVA） ≤0.00 log MAR units in both eyes (Snellen equivalent to 20/20);

You may not qualify if:

  • \. had binocular vision problems; 2.use medications that might affect refractive development; 3.had history of ortho-k or contact lens wear; 4. Ocular surface diseases and other eye diseases which can cause abnormalities of ocular surface; 5. Patients with histories of ocular injury or surgery; 6. Corneal staining and decentration of lens after wearing Ortho-k.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Jingan, 380 Kangding Road, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Zhu Mengjun, MD

CONTACT

86-21-62565920morning5012@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 4, 2018

Study Start

January 11, 2018

Primary Completion

January 11, 2022

Study Completion

January 11, 2022

Last Updated

May 4, 2018

Record last verified: 2017-11

Locations

CN(1)