NCT06162234

Brief Summary

The study aims to observe the long-term changes of ocular（especially fundus） structure and visual function in patients with high myopia, so as to provide evidence for the prevention, diagnosis and prognosis of high myopia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Dec 2023

Typical duration for all trials

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 Progress71%
Dec 2023Sep 2027

First Submitted

Initial submission to the registry

December 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

December 25, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

3.7 years

First QC Date

December 1, 2023

Last Update Submit

December 19, 2023

Conditions

High Myopia

Keywords

ocular biometric parametersRefractive Errors

Outcome Measures

Primary Outcomes (5)

  • Myopic optic nerve changes

    Changes in the optic nerve head morphology and blood supply which are supposed to be related with high myopia，examined by fundus photography，OCT，OCTA，etc

    Baseline and 6 months and 1，2,3,4years

  • Progression of axial length (AL)

    Subjects' axial length and its progression collected by IOL master 700

    Baseline and 6 months and 1，2,3,4years

  • Incidence and progression of visual field (VF) defects

    Variety and progression of visual field defects collected by Humphrey 860 perimetry

    Baseline and 6 months and 1，2,3,4years

  • Loss of best corrected visual acuity（BCVA）

    Incidence of BCVA loss collected by subjective optometry

    Baseline and 6 months and 1，2,3,4years

  • Incidence and progression of myopic maculopathy

    Collected by color fundus photography and ultra-wide fundus photography

    Baseline and 6 months and 1，2,3,4years

Secondary Outcomes (4)

  • Relationship between the changes of visual function and pathological changes among patients with high myopia

    Baseline and 6 months and 1，2,3,4years

  • Structural parameters of anterior segment

    Baseline and 6 months and 1，2,3,4years

  • Intraocular pressure(IOP)

    Baseline and 6 months and 1，2,3,4years

  • Mental state and quality of life

    Baseline and 6 months and 1，2,3,4years

Study Arms (1)

entire cohort

entire cohort made up of high myopia patients（observational study）

Other: observational

Interventions

observationalOTHER

none (observational study)

entire cohort

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First-year college student from Wuhan University

You may qualify if:

  • Voluntarily sign informed consent;
  • Commit to follow the research procedures and cooperate with the whole process of the study;
  • Age ≥18 years old;
  • Best corrected visual acuity ≥0.1;
  • Spherical Equivalent Refraction≤-6.00D or axial length ≥26mm in high myopia group；

You may not qualify if:

  • Unable or unwilling to sign informed consent;
  • Unable to cooperate with the examination;
  • Astigmatism ≤-1.5D；
  • Patients with refractive interstitial opacity so that fundus images cannot be collected；
  • Patients with fundus diseases such as diabetic retinopathy, hypertensive retinopathy, age-related macular degeneration, retinal vein obstruction, retinal artery obstruction, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

tear，saliva

MeSH Terms

Conditions

Refractive Errors

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

QY Wu, MD

CONTACT

+86 18672345926wuqyan@163.com

RH Hu, bachelor

CONTACT

+86 189716695032019305232102@whu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Ophthalmology

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 8, 2023

Study Start

December 25, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

CN(1)