NCT03957642

Brief Summary

To evaluate the diagnostic value of systematic ophthalmologic imaging examination in the diagnosis of embedded optic disc drusen (ODD) in adolescents with mild visual impairment.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 21, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

8 months

First QC Date

May 19, 2019

Last Update Submit

May 21, 2019

Conditions

Optic Disk Drusen

Outcome Measures

Primary Outcomes (1)

  • detection rate of embedded ODD

    detection rate of embedded ODD

    1 week

Eligibility Criteria

Age14 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents with mild visual impairment accompanied by disc flushing, crowded optic disc, and a blurred disc halo.

You may qualify if:

  • Male or female.
  • Age 14-28.
  • The results of visual acuity examination suggest mild visual impairment.
  • The results of ophthalmologic examination showed that the blurred degree of the local boundary of the optic disc was different and the optic disc was congested.

You may not qualify if:

  • patients with amblyopia.
  • patients with neurological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The third affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Optic Disk Drusen

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Xiuhua Jia, Dorctor

    Third Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Zhu, Doctor

CONTACT

138264525640628zhuxiang@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2019

First Posted

May 21, 2019

Study Start

May 21, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations

CN(1)