MyopiaNCT05716776
Effect of Axial Length of the Globe on Retinal Nerve Fibre Thickness
An observational study of Myopia, run by Sohag University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Optical coherence tomography (OCT)
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatient ophthalmology clinic
Who may be able to join
- Healthy volunteers attending the outpatient clinic for surface ocular diseases.
- patients who are cooperative with optical coherence tomography (OCT) device.
Who cannot join
- Glaucoma patients.
- Media opacity (corneal, lens or vitreous opacity)
- Previous ocular surgery.
- Diabetic patients.
- Retinal diseases.
Trial locations and contacts
No sites are listed yet.
Engy Mo Mostafa, MD contact
About this study
Official title: Effect of Axial Length on Peripapillary Retinal Nerve Fibre Layer (RNFL) Using Optical Coherence Tomography (OCT)
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
Read the 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.
- Conditions
- Myopia
- Being tested
- Optical coherence tomography (OCT)
- Keywords
- Axial length, RNFL
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography (OCT)Diagnostic test
Measurement of retinal nerve fibre layer (RNFL) thickness using optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| Group 1 short axial length (AL) | Axial length less than 21 Receives: Diagnostic Test: Optical coherence tomography (OCT) | |
| Group 2 average axial length (AL) | Axial length 21-24 Receives: Diagnostic Test: Optical coherence tomography (OCT) | |
| Group 3 long axial length (AL) | Axial length more than 24 Receives: Diagnostic Test: Optical coherence tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fibre layer (RNFL) thickness
Measuring Retinal nerve fibre layer (RNFL)thickness using OCT
Measured: average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ibrahim Mostafa, Sohag University
- Investigators
- Engy Mo Mostafa, MD, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716776
- Sponsor's protocol ID
- Soh-Med-22-12-01
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Axial Length on Peripapillary Retinal Nerve Fibre Layer (RNFL) Using Optical Coherence Tomography (OCT)
- ClinicalTrials.gov ID
- NCT05716776
- Acronym / sponsor ID
- Soh-Med-22-12-01
- Conditions
- Myopia
- Keywords
- Axial length, RNFL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 short axial length (AL) | – | Diagnostic Test: Optical coherence tomography (OCT)Axial length less than 21 |
| Group 2 average axial length (AL) | – | Diagnostic Test: Optical coherence tomography (OCT)Axial length 21-24 |
| Group 3 long axial length (AL) | – | Diagnostic Test: Optical coherence tomography (OCT)Axial length more than 24 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient ophthalmology clinic
Key inclusion criteria (2 listed)
- Healthy volunteers attending the outpatient clinic for surface ocular diseases.
- patients who are cooperative with optical coherence tomography (OCT) device.
Key exclusion criteria (5 listed)
- Glaucoma patients.
- Media opacity (corneal, lens or vitreous opacity)
- Previous ocular surgery.
- Diabetic patients.
- Retinal diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomography (OCT)Measurement of retinal nerve fibre layer (RNFL) thickness using optical coherence tomography | Diagnostic test | Group 1 short axial length (AL), Group 2 average axial length (AL), Group 3 long axial length (AL) |
Primary outcome
Retinal nerve fibre layer (RNFL) thickness
Time frame: average of one year
Measuring Retinal nerve fibre layer (RNFL)thickness using OCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Engy Mo Mostafa, MD contact
Engy Mo Mostafa, MD study director
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa I Mostafa (01098794745, asmaaelmalah8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fibre layer (RNFL) thickness (time frame: average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.