NCT07241806

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Refractive Errors

Outcome Measures

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)

    two years

Interventions

OCTDEVICE

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 26875007RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • Hougaard JL, Wang M, Fjeldstad JS. Quantitative OCT findings in high myopia and hyperopia. Acta Ophthalmol. 2023;101(4):e315-e322.

    RESULT

  • 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

    RESULT

  • 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.

    RESULT

  • . 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.

    RESULT

  • . 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.

    RESULT

Related Links

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Mariam Sameh Roshdy

CONTACT

+201143288540romaa.sameh83@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 21, 2025

Record last verified: 2025-11