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Completed

NCT Number: NCT07458126

Digital Colorimetric Scale for Recurrent Pterygium Scar Assessment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older.
  • Patients diagnosed with primary or recurrent pterygium.
  • Availability of slit-lamp anterior segment photographs suitable for digital image analysis.
  • Ability to provide informed consent for participation in the study.

Exclusion criteria

  • Presence of other ocular surface diseases that may interfere with conjunctival vascularization assessment.
  • Previous ocular surgery unrelated to pterygium that may alter conjunctival anatomy.
  • Poor quality slit-lamp photographs that do not allow reliable digital image analysis.
  • Incomplete clinical data.

Treatment and study plan

Primary outcomes

  1. Quantitative Assessment of Conjunctival Vascularization Using Digital Colorimetric Image Analysis

    Time frame: Baseline (at time of clinical image acquisition)

    Conjunctival vascularization associated with pterygium will be quantified using digital image analysis of slit-lamp photographs. Images will be processed with Fiji/ImageJ software to measure vascular pixel density and colorimetric intensity values within a defined conjunctival region of interest.

Secondary outcomes

  1. Correlation Between Digital Vascular Density and Clinical Hyperemia Grading

    Time frame: Baseline

    Correlation between vascular density quantified through digital image analysis and clinical grading of conjunctival hyperemia performed during slit-lamp examination.

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

Validation of a Digital Colorimetric Scale for Objective Assessment of Conjunctival Scar in Recurrent Pterygium Using Image Analysis Software

Acronym: DCS-PTER

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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