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Not yet recruitingNCT07241806Updated Nov 21, 2025

Measurment of Optic Disc Parameters, RNFL Thickness and Ganglion Cell Complex in Myopic, Hypermetropic and Emmetropic Patients Using OCT and Axial Length Measurments

An observational study in Refractive Errors, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
266
Ages
18 Years and older
Sex
All
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Study summary

To evaluate the optic disc parameters, thickness of ganglion cell complex (GCC), and thickness of peripapillary retinal nerve fiber layer (RNFL) in myopic and hyperopic and emmetrop patients using optical coherence tomography (OCT), and to correlate these changes with axial length and degree of refractive error.

Read the detailed description

Refractive errors, particularly myopia and hyperopia, are among the most common ocular conditions globally, affecting both children and adults .

Myopia is frequently associated with axial elongation, which may induce structural changes in the posterior segment of the eye such as thinning of the peripapillary retinal nerve fiber layer (RNFL) and alteration of optic disc parameters . Hyperopia, conversely, is linked to shorter axial lengths and has been shown to affect retinal and optic nerve anatomy in distinct ways .

Optical coherence tomography (OCT), particularly spectral-domain OCT (SD-OCT), allows for high-resolution imaging of the RNFL and ganglion cell complex (GCC), which are crucial for visual processing. These layers are known to undergo subtle changes not only due to disease processes like glaucoma or optic neuropathies but also as a result of anatomical differences induced by refractive status .

While many studies have independently evaluated RNFL or GCC in myopic and hyperopic patients, few have directly compared these two refractive states while correlating structural findings with axial length and refractive error magnitude . Including an emmetropic control group provides a normative benchmark, enhancing the clinical relevance of the findings .

This study seeks to fill this gap by offering a comparative structural analysis using OCT, aiming to enhance diagnostic sensitivity and understanding of optic nerve and macular changes in various refractive profiles.

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Conditions studied

  • Refractive Errors

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03

In context

Refractive Errors

420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.

This study's planned enrollment of 266 is above the median of 150 across 108 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults age starting from 18 years old Diagnosed with myopia (≤ -0.50 D) or hyperopia (≥ +0.50 D) Clear ocular media for high-quality OCT imaging No prior ocular surgeries Willing to provide informed consent IOP below 21 exculuding Presence of glaucoma or optic nerve pathologies Retinal diseases or degenerative changes Systemic diseases affecting the eye (e.g., diabetes, hypertension) History of trauma or intraocular surgery High astigmatism (> ±2.00 D) Poor OCT image quality

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults age starting from 18 years old Diagnosed with myopia (≤ -0.50 D) or hyperopia (≥ +0.50 D) Clear ocular media for high-quality OCT imaging No prior ocular surgeries Willing to provide IOP below 21

Exclusion criteria

Exclusion Criteria:

  • Presence of glaucoma or optic nerve pathologies Retinal diseases or degenerative changes Systemic diseases affecting the eye (e.g., diabetes, hypertension) History of trauma or intraocular surgery High astigmatism (> ±2.00 D) Poor OCT image quality
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
266 participants (estimated)
Patient registry
No

Interventions

  • DeviceOCT

    Axial length measurement (using A-scan) Spectral-domain OCT: All the patients will undergo OCT imaging using NIDEK RS-330 Retina scan duo 2 (SD-OCT)(CO-LTD made in Japan 2017) with scan speed 70.000 axial scans per second and wavelength of 880 nm for: Peripapillary RNFL thickness in all quadrants GCC thickness (average, superior, inferior,nasal,temporal) Optic disc parameters (disc area, cup/disc ratio, rim area)

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What researchers measure

Primary outcomes

  1. To evaluate the optic disc parameters, thickness of ganglion cell complex (GCC), and thickness of peripapillary retinal nerve fiber layer (RNFL) in myopic and hyperopic and emmetrop patients using optical coherence tomography (OCT)

    To evaluate the optic disc parameters, thickness of ganglion cell complex (GCC), and thickness of peripapillary retinal nerve fiber layer (RNFL) in myopic and hyperopic and emmetrop patients using optical coherence tomography (OCT)

    Time frame: two years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11. PubMed 26875007 ↗
  • Chen Y, Li X, Wang J, et al. Recent large-sample findings reinforcing the relationship between myopia (axial elongation) and reduced RNFL thickness, with discussion of magnification correction. Sci Rep. 2024;14(1):12567.
  • Wu Z, Huang J, Wang Y, et al. Retinal structural changes associated with high refractive errors: A comparative OCT analysis. Eye (Lond). 2024;38(1):112-120.
  • Hougaard JL, Wang M, Fjeldstad JS. Quantitative OCT findings in high myopia and hyperopia. Acta Ophthalmol. 2023;101(4):e315-e322.
  • Liu S, Chen J, Xu Y, Li Y, Zhang X. Effects of refractive error on GCC and RNFL thickness: a meta-analysis. Eye Vis (Lond). 2023;10(1):14
  • Wang D, Zhang Y, Chen H, Li L, Zhou Y. Evaluation of RNFL thickness in hyperopic eyes: a comparative OCT-based study. Int J Ophthalmol. 2022;15(4):599-605.
  • . Leung CK, Yu M, Weinreb RN, Mak HK, Lai G, Ye C, et al. Impact of axial length on optic disc and retinal nerve fiber layer measurements. Invest Ophthalmol Vis Sci. 2011;52(1):291-9.
  • . Kim M, Choi EH, Lee HS, Park SW, Kim JH, Yu YS. Peripapillary and macular retinal thickness in high myopia measured with OCT. BMC Ophthalmol. 2020;20(1):285.

Related links

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2026; primary completion for Nov 2027, 22 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2025
First posted
Nov 21, 2025
StartEst.
Jan 2026
Primary completionEst.
Nov 2027
CompletionEst.
Dec 2027
Last update
Nov 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07241806
Lead sponsor
Assiut University
Responsible party
Mariam Smeh Roshdy (doctor, Assiut University) — Principal investigator
First posted
Nov 21, 2025
Start date
Jan 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 21, 2025

Study contacts

Mariam Sameh Roshdy
Contact
romaa.sameh83@gmail.com
+201143288540

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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