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CompletedNCT07458126DCS-PTERUpdated Mar 9, 2026

Digital Colorimetric Scale for Recurrent Pterygium Scar Assessment

An observational study in Recurrent Pterygium and Conjunctival Scarring, sponsored by Instituto de Oftalmología Fundación Conde de Valenciana. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Instituto de Oftalmología Fundación Conde de Valenciana · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Recurrent Pterygium
  • Conjunctival Scarring

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Keywords

  • Pterygium
  • Recurrent Pterygium
  • Conjunctival Scarring
  • Digital Image Analysis
  • Colorimetric Scale
  • ImageJ
03

In context

Pterygium

109 studies on the registry are indexed under Pterygium; 9 are open to participants now.

This study's enrollment of 25 is below the median of 58 across 14 observational studies indexed under Pterygium.

Browse Pterygium studies →

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana is the lead sponsor of 45 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for participation in the study.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

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

    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.

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

Secondary outcomes

  1. Correlation Between Digital Vascular Density and Clinical Hyperemia Grading

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

    Time frame: Baseline

07

Study locations

1 site
  • ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
    Mexico City, Mexico
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07458126
Lead sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
Responsible party
Sponsor
First posted
Mar 9, 2026
Start date
Aug 22, 2024
Primary completion
Feb 25, 2025
Completion
Feb 25, 2025
Last update
Mar 9, 2026

Study contacts

Jose Adrian Negrete, MD
principal investigator · ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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