Recurrent PterygiumDCS-PTERNCT07458126
Digital Colorimetric Scale for Recurrent Pterygium Scar Assessment
An observational study of Recurrent Pterygium and Conjunctival Scarring, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Pterygium, Conjunctival Scarring
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- 22 Aug 2024to 25 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
Mexico City
About this study
Official title: 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.
Read more
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.
- Conditions
- Recurrent Pterygium, Conjunctival Scarring
- Keywords
- Pterygium, Recurrent Pterygium, Conjunctival Scarring, Digital Image Analysis, Colorimetric Scale, ImageJ
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start22 Aug 2024
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent PterygiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Adrian Negrete, MD, Principal investigator, ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458126
- Sponsor's protocol ID
- PTER-Color-2024
- Acronym
- DCS-PTER
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Digital Colorimetric Scale for Objective Assessment of Conjunctival Scar in Recurrent Pterygium Using Image Analysis Software
- ClinicalTrials.gov ID
- NCT07458126
- Acronym / sponsor ID
- DCS-PTER / PTER-Color-2024
- Conditions
- Recurrent Pterygium, Conjunctival Scarring
- Keywords
- Pterygium, Recurrent Pterygium, Conjunctival Scarring, Digital Image Analysis, Colorimetric Scale, ImageJ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlation Between Digital Vascular Density and Clinical Hyperemia Grading
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: 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.
Related trials for Recurrent Pterygium
Not yet recruiting
Comparing Two Surgical Methods to Prevent Pterygium Regrowth
Pterygium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Adrian Negrete, MD principal investigator
✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pterygium and Conjunctival Scarring, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Assessment of Conjunctival Vascularization Using Digital Colorimetric Image Analysis (time frame: Baseline (at time of clinical image acquisition)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.