跳至主要内容
临床试验/NCT07458126
NCT07458126已完成不适用

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

Instituto de Oftalmología Fundación Conde de Valenciana1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年8月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Quantitative Assessment of Conjunctival Vascularization Using Digital Colorimetric Image Analysis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Recurrent Pterygium

Participants diagnosed with recurrent pterygium. Slit-lamp photographs of the anterior segment are obtained and analyzed using digital colorimetric image analysis to quantify conjunctival vascularization and scarring.

Primary Pterygium

Participants diagnosed with primary pterygium used as a comparison group. Slit-lamp images are analyzed using the same digital colorimetric image analysis to evaluate conjunctival vascularization and tissue characteristics.

结局指标

主要结局

Quantitative Assessment of Conjunctival Vascularization Using Digital Colorimetric Image Analysis

时间窗: 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.

次要结局

  • Correlation Between Digital Vascular Density and Clinical Hyperemia Grading(Baseline)

研究者

发起方
Instituto de Oftalmología Fundación Conde de Valenciana
申办方类型
Other
责任方
Sponsor

研究点 (1)

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