NCT05716776

Brief Summary

the goal of this obsrevational study is to learn about retinal nerve fibres and if their numbers changed with axial length of the globe or not. the main question to answer is there is effect of long axial length on the thickness of the retinal nerve fibers participants will be asked to:

  • measure the axial length with ultrasound
  • measure the thickness of retinal nerve fibers with optical coherence tomography

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

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

January 8, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

January 8, 2023

Last Update Submit

February 6, 2023

Conditions

Keywords

Axial lengthRNFL

Outcome Measures

Primary Outcomes (1)

  • Retinal nerve fibre layer (RNFL) thickness

    Measuring Retinal nerve fibre layer (RNFL)thickness using OCT

    average of one year

Study Arms (3)

Group 1 short axial length (AL)

Axial length less than 21

Diagnostic Test: Optical coherence tomography (OCT)

Group 2 average axial length (AL)

Axial length 21-24

Diagnostic Test: Optical coherence tomography (OCT)

Group 3 long axial length (AL)

Axial length more than 24

Diagnostic Test: Optical coherence tomography (OCT)

Interventions

Measurement of retinal nerve fibre layer (RNFL) thickness using optical coherence tomography

Group 1 short axial length (AL)Group 2 average axial length (AL)Group 3 long axial length (AL)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient ophthalmology clinic

You may qualify if:

  • Healthy volunteers attending the outpatient clinic for surface ocular diseases.
  • patients who are cooperative with optical coherence tomography (OCT) device.

You may not qualify if:

  • Glaucoma patients.
  • Media opacity (corneal, lens or vitreous opacity)
  • Previous ocular surgery.
  • Diabetic patients.
  • Retinal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Engy Mo Mostafa, MD

    Sohag University

    STUDY DIRECTOR

Central Study Contacts

Engy Mo Mostafa, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, ophthalmology resident

Study Record Dates

First Submitted

January 8, 2023

First Posted

February 8, 2023

Study Start

February 1, 2023

Primary Completion

June 1, 2023

Study Completion

January 1, 2024

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share