OCT Study RNFL and Macular ThicknessNCT05486741
Retinal Nerve Fiber Layer Thickness and Macular Thickness in Myopia, Hyperopia and Emmetropia : An OCT Study
An observational study of OCT Study RNFL and Macular Thickness, run by Assiut University.
Trial summary
The purpose of this study is to investigate the variability of RNFL and macular thickness between myopia , hyper metropia and emmetropia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- OCT Study RNFL and Macular Thickness
- What is being tested?
- Optical cehernce tomography
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Dec 2023
- 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 70 years
- All sexes
- Adult, Older adult
Study population: patients with errors of refraction devided into 3 groups myopes (≤ -1.0 D) ; emmetropes (> -1.0 to < * 1.0 D) and hypermetropia (≥ +1.0D).
Who may be able to join
- All individuals having similar type of refractive status in both eyes and with no known confounding factor affecting retinal intensity or CDVA and willing to participate.
Who cannot join
- • Eyes with amplyopia
- Patients having posterior segment pathology or media opacity
- Patients with history of glaucoma
- History of retinal laser therapy
- History of ocualr trauma
- Any medical disease that prevents patients from positioning on the device
Trial locations and contacts
No sites are listed yet.
Magdy Mohamed mostafa contact
About this study
Official title: Retinal Nerve Fiber Layer Thickness and Macular Thinckness in Myopia, Hyperopia and Emmetropia : An OCT Study
The purpose of this study is to investigate the variability of RNFL and macular thickness between myopia , hyper metropia and emmetropia
Read the detailed description
The world health organization (WHO) has estimated that the visual impairment caused by uncorrected refractive errors to be present in 153 million people worldwide (1) the prevalence of myopia ranges from 22.7% to 38.7% in large population study According to the WHO regions the estimated prevalence (EP) of hyperopia is 30.6% with the lowest EP in south east Asia 2.2% and the highest EP in the Americas 14.3% (2-3) During optic nerve development 2.85 million nerve fibers exist but by the third trimester we lose about 35% of these fibers (4) and the perpapillary retinal nerve fiber layer (RNFL) thickness will continue to decrease with advancing age (5). The relationship of the RNFL thickness with the refractive errors has been extensively investigated in adults and in children (6) and there was significant increase in the RNFL thickness in hypermetrope than in emmetrope and myope Understanding the derminants that affect the RNFL reserve helps us in the diagnosis and monitoring of optic nerve diseases. In macular region the thickness measured through optocal coherent tomography OCT shows high variability with value ranging from 190mm (centerpoint) to 389 mm (superior inner/nasal inner macula) (7) for both retinal and macular regions while decreasing in the retinal thickness has been reported with increasing age. Different studies have shown racial differences in RNFL thickness (8) white race (9) and myopia which has high prevelance in East Asian regions (10-12) have been associated with thinner RNFL (11) on the contrary Asian or Hispanic race has been associated with a thicker RNFL
- Conditions
- OCT Study RNFL and Macular Thickness
- Being tested
- Optical cehernce tomography
- Keywords
- OCT study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical cehernce tomographyOther
OCT macula and disc
| Study group | Role | What they receive |
|---|---|---|
| Myopes | myopes (≤ -1.0 D) Receives: Other: Optical cehernce tomography | |
| Hyperopes | hyperopia (≥ +1.0D). Receives: Other: Optical cehernce tomography | |
| Emmetropes | emmetropes (> -1.0 to <
* 1.0 D) Receives: Other: Optical cehernce tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fiber layer thickness and macular thickness in myopia , hyperopia and emmetropia : An OCT study
investigate the variability of RNFL and macular thickness between myopia , hyper metropia and emmetropia The peripapillary RNFL thickness in central ,perimacular and paramacular regions will be measured using the OCT and compared between three groups of refractive states
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OCT Study RNFL and Macular ThicknessStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirna Tawab Saied, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486741
- Sponsor's protocol ID
- OCT study in refractive errors
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hussein M, Ibrahim S, Taha A, Magdy R. The impact of error of refraction and retinal nerve fiber layer thickness on cognitive functions in adults with bilateral myopia. Int J Neurosci. 2023 Mar;133(3):290-295. doi: 10.1080/00207454.2021.1910260. Epub 2021 May 17.
PubMed 33781167Leung CK, Mohamed S, Leung KS, Cheung CY, Chan SL, Cheng DK, Lee AK, Leung GY, Rao SK, Lam DS. Retinal nerve fiber layer measurements in myopia: An optical coherence tomography study. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5171-6. doi: 10.1167/iovs.06-0545.
PubMed 17122099Wang Q, Klein BE, Klein R, Moss SE. Refractive status in the Beaver Dam Eye Study. Invest Ophthalmol Vis Sci. 1994 Dec;35(13):4344-7.
PubMed 8002254
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Nerve Fiber Layer Thickness and Macular Thinckness in Myopia, Hyperopia and Emmetropia : An OCT Study
- ClinicalTrials.gov ID
- NCT05486741
- Acronym / sponsor ID
- OCT study in refractive errors
- Conditions
- OCT Study RNFL and Macular Thickness
- Keywords
- OCT study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Aug 2022 (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 purpose of this study is to investigate the variability of RNFL and macular thickness between myopia , hyper metropia and emmetropia
Detailed description
The world health organization (WHO) has estimated that the visual impairment caused by uncorrected refractive errors to be present in 153 million people worldwide (1) the prevalence of myopia ranges from 22.7% to 38.7% in large population study According to the WHO regions the estimated prevalence (EP) of hyperopia is 30.6% with the lowest EP in south east Asia 2.2% and the highest EP in the Americas 14.3% (2-3) During optic nerve development 2.85 million nerve fibers exist but by the third trimester we lose about 35% of these fibers (4) and the perpapillary retinal nerve fiber layer (RNFL) thickness will continue to decrease with advancing age (5). The relationship of the RNFL thickness with the refractive errors has been extensively investigated in adults and in children (6) and there was significant increase in the RNFL thickness in hypermetrope than in emmetrope and myope Understanding the derminants that affect the RNFL reserve helps us in the diagnosis and monitoring of optic nerve diseases. In macular region the thickness measured through optocal coherent tomography OCT shows high variability with value ranging from 190mm (centerpoint) to 389 mm (superior inner/nasal inner macula) (7) for both retinal and macular regions while decreasing in the retinal thickness has been reported with increasing age. Different studies have shown racial differences in RNFL thickness (8) white race (9) and myopia which has high prevelance in East Asian regions (10-12) have been associated with thinner RNFL (11) on the contrary Asian or Hispanic race has been associated with a thicker RNFL
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myopes | – | Other: Optical cehernce tomographymyopes (≤ -1.0 D) |
| Hyperopes | – | Other: Optical cehernce tomographyhyperopia (≥ +1.0D). |
| Emmetropes | – | Other: Optical cehernce tomographyemmetropes (> -1.0 to < * 1.0 D) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with errors of refraction devided into 3 groups myopes (≤ -1.0 D) ; emmetropes (> -1.0 to < * 1.0 D) and hypermetropia (≥ +1.0D).
Key inclusion criteria (1 listed)
- All individuals having similar type of refractive status in both eyes and with no known confounding factor affecting retinal intensity or CDVA and willing to participate.
Key exclusion criteria (6 listed)
- • Eyes with amplyopia
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 cehernce tomographyOCT macula and disc | Other | Emmetropes, Hyperopes, Myopes |
Primary outcome
Retinal nerve fiber layer thickness and macular thickness in myopia , hyperopia and emmetropia : An OCT study
Time frame: Baseline
investigate the variability of RNFL and macular thickness between myopia , hyper metropia and emmetropia The peripapillary RNFL thickness in central ,perimacular and paramacular regions will be measured using the OCT and compared between three groups of refractive states
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 33781167Hussein M, Ibrahim S, Taha A, Magdy R. The impact of error of refraction and retinal nerve fiber layer thickness on cognitive functions in adults with bilateral myopia. Int J Neurosci. 2023 Mar;133(3):290-295. doi: 10.1080/00207454.2021.1910260. Epub 2021 May 17.
- Background: PubMed 17122099Leung CK, Mohamed S, Leung KS, Cheung CY, Chan SL, Cheng DK, Lee AK, Leung GY, Rao SK, Lam DS. Retinal nerve fiber layer measurements in myopia: An optical coherence tomography study. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5171-6. doi: 10.1167/iovs.06-0545.
- Background: PubMed 8002254Wang Q, Klein BE, Klein R, Moss SE. Refractive status in the Beaver Dam Eye Study. Invest Ophthalmol Vis Sci. 1994 Dec;35(13):4344-7.
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.
Magdy Mohamed mostafa contact
Questions about this trial
What is this clinical trial studying?
An observational study of OCT Study RNFL and Macular Thickness, run by Assiut 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 1 inclusion and 6 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 4 Aug 2022. 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 Mirna Tawab Saied (01221353527, mirnatawab56@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fiber layer thickness and macular thickness in myopia , hyperopia and emmetropia : An OCT study (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486741, which also lists 3 linked publications.
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 4 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.