NCT04045951

Brief Summary

In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between myopia children using myopia prediction algorithm and myopia children without using myopia prediction algorithm

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
2,138

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration 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

First Submitted

Initial submission to the registry

August 2, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

August 2, 2019

Last Update Submit

August 6, 2019

Conditions

Myopia

Keywords

Vision DisordersArtificial intelligenceMyopia prediction

Outcome Measures

Primary Outcomes (2)

  • Incidence of SER development of at least -1.0 dioptres (D)

    SER: spherical equivalent refraction, sphere + ½ 360 cylinder; SER development of at least -1.0 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 2 year

    up to 2 year

  • Incidence of SER development of at least -0.5 dioptres (D)

    SER: spherical equivalent refraction, sphere + ½ 360 cylinder; SER development of at least -0.5 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 1 year

    up to 1 year

Secondary Outcomes (12)

  • Changes in SER \ and AL

    Up to 1 year

  • Changes in SER \ and AL

    Up to 2 year

  • Changes in proportion of children using atropine

    Up to 1 year

  • Changes in proportion of children using atropine

    Up to 2 year

  • Changes in proportion of children using orthokeratology lenses

    Up to 1 year

  • +7 more secondary outcomes

Study Arms (2)

Using myopia prediction algorithm

EXPERIMENTAL

After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children. Meanwhile, myopia prediction algorithm will be used to predict SER at 3 years.

Other: Myopia prediction algorithm

Not using myopia prediction algorithm

NO INTERVENTION

After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.

Interventions

Myopia prediction algorithmOTHER

Candidate predictors included age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 years.

Using myopia prediction algorithm

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 8-10
  • Has the record of eye refraction examined in the past year, SER\<-0.5D
  • Current BCVA≥0.8, SER\<-0.5D, Astigmatism less than 1.50 D, anisometropia less than 1.50 D
  • Written informed consents provided

You may not qualify if:

  • Definitive diagnosis of other diseases except for refractive error
  • Previous eye surgery
  • Previous usage of orthokeratology lenses and atropine
  • Unwilling to participate in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Centre

Guangzhou, Guangdong, 510623, China

RECRUITING

MeSH Terms

Conditions

MyopiaVision Disorders

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Haotian Lin

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yahan Yang

CONTACT

+8615521013933yah.yang39@hotmail.com

Haotian Lin

CONTACT

+8613802793086haot.lin@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessors involved in data management and analysis will be blinded to the group assignment. The study participants, the investigators responsible for randomization will not be masked.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 6, 2019

Study Start

August 3, 2019

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

CN(1)