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

NCT ID: NCT05716776

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-28

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. Detailed ophthalmological and medical history.
2. Detailed slit lamp examination.
3. Visual acuity (VA) and best corrected visual acuity (BCVA) using Snellen chart and recorded in decimal notation.
4. Auto refraction using Topcon auto refractometer RM-800.
5. Optical coherence tomography (OCT) scan of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness using Avanti scanner Optovue.
6. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 short axial length (AL)

Axial length less than 21

Optical coherence tomography (OCT)

Intervention Type DIAGNOSTIC_TEST

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

Group 2 average axial length (AL)

Axial length 21-24

Optical coherence tomography (OCT)

Intervention Type DIAGNOSTIC_TEST

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

Group 3 long axial length (AL)

Axial length more than 24

Optical coherence tomography (OCT)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optical coherence tomography (OCT)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Asmaa Ibrahim Mostafa

Principal Investigator, ophthalmology resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Engy Mo Mostafa, MD

Role: STUDY_DIRECTOR

Sohag University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Asmaa I Mostafa

Role: CONTACT

01098794745

Engy Mo Mostafa, MD

Role: CONTACT

01005643587

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med-22-12-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.