NCT07458126

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Recurrent PterygiumConjunctival Scarring

Keywords

PterygiumRecurrent PterygiumConjunctival ScarringDigital Image AnalysisColorimetric ScaleImageJ

Outcome Measures

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.

    Baseline (at time of clinical image acquisition)

Secondary Outcomes (1)

  • Correlation Between Digital Vascular Density and Clinical Hyperemia Grading

    Baseline

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Mexico City, Mexico

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • Jose Adrian Negrete, MD

    ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

August 22, 2024

Primary Completion

February 25, 2025

Study Completion

February 25, 2025

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

ME(1)