Clinical trial · Observational
Observational Study of Iris Tumors
NCT03809585CI-TRIAL-00094787recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational study using OCT angiography to assist with tumor characterization in melanotic and amelanotic iris lesions. OCT angiography data from healthy eyes will be compared to eyes with various types of iris tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Iris Tumor | Iris Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Iris Tumors
- description
- This group will consist of 50 adults age 18 or older who have been diagnosed with either melanotic or amelanotic iris tumors. Iris tumor diagnosis will be confirmed by biopsy when possible or based upon clinical features (if patient declines biopsy or if not medically indicated) according to standard-of-care guidelines.
- label
- Healthy Controls
- description
- This group will consist of 50 adults age 18 and older who have healthy eyes.
Primary outcomes (1)
- measure
- Tumor Thickness in Benign vs Malignant Iris Lesions
- timeFrame
- 6 months
- description
- OCT/OCTA will be used to compare tumor thickness measurements against the conventional Ultrasonic Biomicroscopy (UBM) device. Tumor thickness will be measured in millimeters, and growth of 0.5 mm or greater will be used to differentiate malignant from benign lesions.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for tumor group: * Eyes with diagnosis of melanotic or amelanotic iris tumors Inclusion Criteria for healthy control group: * Eyes without iris defects or lesions Exclusion Criteria (both groups): * Inability to give informed consent * Inability to maintain stable fixation for OCT imaging * Inability to commit to required study visits * Eyes with concurrent retinal diseases, glaucoma, or conditions that in the opinion of the investigators might affect iris circulation * Mature cataracts if found to limit visual potential to worse than 20/40
References
Publications (0)
Data not yet available
No reference posted for this study.