Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 28, 2026
Open Peer Review Period: Apr 1, 2026 - May 27, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Ocular Biometric and Fundus Characteristics in High Myopia: A Hospital-Based Cross-Sectional Study Protocol
ABSTRACT
Background:
High myopia (spherical equivalent refractive error (SER) ≤ -6.00 diopters (D)) is a major global cause of visual impairment associated with structural ocular complications including myopic macular degeneration, retinal detachment, glaucoma, and cataract. Structural alterations including axial elongation, corneal remodeling, and fundus changes remain incompletely characterized across varying degrees of high myopia in Indian tertiary care settings.
Objective:
To evaluate ocular biometric parameters and fundus characteristics in patients with high myopia and examine their association with the severity of myopia.
Methods:
This hospital-based cross-sectional observational study will be conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital (AVBRH), Jawaharlal Nehru Medical College (JNMC), Datta Meghe Institute of Higher Education and Research (DU) (DMIHER), Wardha, India. A minimum of 140 participants aged 10 to 50 years with high myopia (SER ≤ -6.00 D in at least one eye on cycloplegic refraction) will be consecutively enrolled over 2 years. Participants will undergo standardized ophthalmic assessment including best-corrected visual acuity (BCVA; converted to logMAR for analysis), cycloplegic refraction confirmed by autorefractometry, slit-lamp biomicroscopy, automated keratometry, ultrasound pachymetry, contact A-scan biometry, and dilated fundus examination. Fundus findings will be graded using the Meta-Analysis for Pathologic Myopia (META-PM) classification. Data normality will be assessed by the Shapiro-Wilk test. Associations between refractive error severity and ocular parameters will be evaluated using Pearson or Spearman correlation coefficients. Group comparisons will be conducted using one-way analysis of variance (ANOVA) or Kruskal-Wallis tests. Categorical comparisons will use the chi-square test. Inter-eye correlation will be addressed using generalized estimating equations (GEE). All analyses will be performed in SPSS version 23.
Results:
The study has received ethical approval from the Institutional Ethics Committee (IEC) of DMIHER (DU) (Ref. No. DMIHER(DU)/IEC/2025/393; July 9, 2025). Participant enrollment commenced in January 2026 and is ongoing. Results are anticipated for publication by 2027 to 2028.
Conclusions:
This study will provide region-specific data on ocular biometric and structural changes in high myopia to inform evidence-based clinical monitoring and management strategies. Clinical Trial: Registered with the Clinical Trials Registry of India (CTRI/2025/12/099253; registered December 16, 2025).
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