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Validation of a Digital Colorimetric Scale for Objective Assessment of Conjunctival Scar in Recurrent Pterygium Using Image Analysis Software
This observational study aims to evaluate and validate a digital colorimetric scale for the objective assessment of conjunctival scarring in patients with recurrent pterygium. Pterygium is a fibrovascular growth of the conjunctiva that may recur after surgical removal, and the evaluation of postoperative scarring is often subjective during clinical examination. Digital photographs of the anterior segment of the eye will be obtained using slit-lamp imaging. These images will be analyzed using image processing software (Fiji/ImageJ) to quantify colorimetric and vascular parameters of the conjunctival scar tissue. Measurements such as hyperemia and vascular density will be obtained through digital image analysis algorithms. The study will assess whether the proposed digital colorimetric scale provides an objective and reproducible method for evaluating conjunctival scarring associated with recurrent pterygium. Interobserver agreement and statistical analyses will be performed to determine the reliability of the measurements. The results of this study may contribute to improving the objective evaluation of postoperative conjunctival changes and may help standardize the clinical assessment of pterygium recurrence.
Pterygium is a common ocular surface disorder characterized by a fibrovascular proliferation of conjunctival tissue extending onto the cornea. Despite surgical treatment, recurrence remains a frequent complication, and postoperative conjunctival scarring is often associated with disease recurrence and ocular surface inflammation. Currently, the clinical evaluation of conjunctival scarring and hyperemia is largely subjective and depends on slit-lamp examination, which may lead to variability between observers. The objective evaluation of conjunctival vascularization and scar-related changes could improve the standardization of postoperative assessments and allow better monitoring of disease progression or recurrence. Digital image analysis has emerged as a useful tool for quantifying ocular surface features such as vascular density, redness, and tissue morphology. The purpose of this observational study is to evaluate and validate a digital colorimetric scale designed to objectively quantify conjunctival scarring associated with recurrent pterygium. The study will analyze anterior segment photographs obtained during routine ophthalmologic examinations. Digital slit-lamp photographs will be collected from patients diagnosed with recurrent pterygium. Images will be analyzed using the open-source software Fiji/ImageJ, which allows quantitative analysis of colorimetric and vascular parameters. Image processing algorithms will be applied to extract objective measurements related to conjunctival redness and vascular density within the scarred conjunctival tissue. Measurements will be obtained from standardized regions of interest within the conjunctiva. Quantitative parameters will include colorimetric intensity values, vascular pixel density, and other digital markers of conjunctival hyperemia. These measurements will be compared with clinical assessments performed by ophthalmologists in order to evaluate the reliability and reproducibility of the proposed colorimetric scale. Statistical analyses will be performed to determine the correlation between the digital measurements and clinical grading systems. Interobserver agreement and measurement reproducibility will also be evaluated. The findings of this study may contribute to the development of standardized digital tools for the objective assessment of conjunctival scarring in patients with recurrent pterygium. Such tools may improve clinical monitoring and facilitate future research on ocular surface diseases and postoperative outcomes.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
Mexico City, Mexico
Start Date
August 22, 2024
Primary Completion Date
February 25, 2025
Completion Date
February 25, 2025
Last Updated
March 9, 2026
25
ACTUAL participants
Lead Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
NCT04419038
NCT02486484
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT02059837