- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07241806
Measurment of Optic Disc Parameters, RNFL Thickness and Ganglion Cell Complex in Myopic, Hypermetropic and Emmetropic Patients Using OCT and Axial Length Measurments
Correlation Between Axial Length and Degree of Refractive Error With Optic Disc Parameters , Ganglion Cell Complex and Peripapillary RNFL Thickness
Study Overview
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mariam Sameh Roshdy
- Phone Number: +201143288540
- Email: romaa.sameh83@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 informed consent IOP below 21
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCT in refractive error
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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