NCT05717855

Brief Summary

Evaluation of prenatal optic chiasm (OC) is important for the differential diagnosis of septo-optic dysplasia (SOD), which is a congenital optic disc anomaly, and the absence of the cavum septum pellucidum (CSP). Septo-optic dysplasia is associated with a wide range of neurological abnormalities, including hypoplasia of the visual pathways, CSP agenesis, and developmental delay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

January 25, 2023

Last Update Submit

February 5, 2023

Conditions

2D UltrasoundCavum Septum PellucidumSeptooptic DysplasiaOptic ChiasmaWillis Polygon

Outcome Measures

Primary Outcomes (3)

  • Calculation of average width of OC according to gestational week in millimeter

    2 months

  • Calculation of average height of OC according to gestational week in millimeter

    2 months

  • Calculation of average area of OC according to gestational week millimeter square

    2 months

Study Arms (1)

Screening septooptic dysplasia

OTHER

Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia

Diagnostic Test: Displaying optic chiasm for screening septooptic dysplasia

Interventions

Displaying optic chiasm for screening septooptic dysplasiaDIAGNOSTIC_TEST

Displaying and measuring the width and length of the optic chiasm for screening septooptic dysplasia with ultrasound between 16-20 weeks of gestation

Also known as: Measuring the width and length of the optic chiasm for screening septooptic dysplasia
Screening septooptic dysplasia

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged greater than 18 years old
  • having singleton pregnancy

You may not qualify if:

  • being under the age of 18
  • having IVF pregnancy
  • having multiple pregnancy
  • comorbidity during pregnancy
  • smoking history
  • presence of familial genetic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Septo-Optic Dysplasia

Condition Hierarchy (Ancestors)

Congenital Cranial Dysinnervation DisordersOculomotor Nerve DiseasesOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesAgenesis of Corpus CallosumNervous System MalformationsOptic Nerve HypoplasiaEye DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 8, 2023

Study Start

September 21, 2020

Primary Completion

March 21, 2021

Study Completion

April 21, 2021

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

TU(1)