Digital Colorimetric Scale for Recurrent Pterygium Scar Assessment (DCS-PTER)

March 3, 2026 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with primary or recurrent pterygium evaluated at an ophthalmology clinic. Slit-lamp photographs of the anterior segment are obtained during routine clinical evaluation and analyzed using digital image analysis to quantify conjunctival vascularization and colorimetric characteristics.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (at time of clinical image acquisition)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Investigators

  • Principal Investigator: Jose Adrian Negrete, MD, ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2024

Primary Completion (Actual)

February 25, 2025

Study Completion (Actual)

February 25, 2025

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTER-Color-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to patient confidentiality and institutional data protection policies. Only aggregated results will be reported in scientific publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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