Effect of Axial Length of the Globe on Retinal Nerve Fibre Thickness

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05716776

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Diagnostic Test: Optical coherence tomography (OCT)

Detailed Description

Aim of the work:

To investigate the effect of axial length on the peripapillary retinal nerve fiber layer.

Patients and methods Study design: Cross sectional comparative study. Location: Ophthalmology department, Sohag teaching hospital. Ethical approval: A written informed consent will be taken from all patients about the aim of the study, the nature of the planned investigation. An approval of the ethical committee of Sohag Faculty of Medicine will be fulfilled.

Methodology The study will include 80 patients healthy volunteers who underwent ophthalmologic examinations including retinal nerve fiber layer (RNFL) thickness analysis with optical coherence tomography (OCT), auto refraction, and axial length measurement.

Inclusion criteria:

Healthy volunteers attending the outpatient clinic for surface ocular diseases.

Exclusion criteria:

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

Method of the study:

Detailed ophthalmological and medical history.
Detailed slit lamp examination.
Visual acuity (VA) and best corrected visual acuity (BCVA) using Snellen chart and recorded in decimal notation.
Auto refraction using Topcon auto refractometer RM-800.
Optical coherence tomography (OCT) scan of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness using Avanti scanner Optovue.
Axial length (AL) measured by E-Z scan 5500 sonomed A-scan ultrasound and biometry.

The patients will be divided into 3 groups:

Group 1 patients with axial length less than 21 mm. Group 2 patients with axial length 21-24 mm. Group 3 patients with axial length more than 24 mm.

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Effect of Axial Length on Peripapillary Retinal Nerve Fibre Layer (RNFL) Using Optical Coherence Tomography (OCT)

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Group 1 short axial length (AL) Axial length less than 21	Diagnostic Test: Optical coherence tomography (OCT) Measurement of retinal nerve fibre layer (RNFL) thickness using optical coherence tomography
Group 2 average axial length (AL) Axial length 21-24	Diagnostic Test: Optical coherence tomography (OCT) Measurement of retinal nerve fibre layer (RNFL) thickness using optical coherence tomography
Group 3 long axial length (AL) Axial length more than 24	Diagnostic Test: Optical coherence tomography (OCT) Measurement of retinal nerve fibre layer (RNFL) thickness using optical coherence tomography

Arm

Intervention/Treatment

Group 1 short axial length (AL)

Axial length less than 21

Diagnostic Test: Optical coherence tomography (OCT)

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

Group 2 average axial length (AL)

Axial length 21-24

Diagnostic Test: Optical coherence tomography (OCT)

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

Group 3 long axial length (AL)

Axial length more than 24

Diagnostic Test: Optical coherence tomography (OCT)

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

Outcome Measures

Primary Outcome Measures

Retinal nerve fibre layer (RNFL) thickness [average of one year]
Measuring Retinal nerve fibre layer (RNFL)thickness using OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sohag University

Investigators

Study Director: Engy Mo Mostafa, MD, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asmaa Ibrahim Mostafa, Principal Investigator, ophthalmology resident, Sohag University

ClinicalTrials.gov Identifier:

NCT05716776

Other Study ID Numbers:

Soh-Med-22-12-01

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 8, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Asmaa Ibrahim Mostafa, Principal Investigator, ophthalmology resident, Sohag University

Axial length

RNFL

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Feb 8, 2023