Observational Study of Iris Tumors

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Les sponsors

Oregon Health and Science University

Collaborateurs

National Eye Institute (NEI)

ESSAI CLINIQUE: NCT03809585

BioSeek: nct03809585

Mots clés

neoplasms

Abstrait

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.

Rendez-vous

Dernière vérification:	01/31/2020
Première soumission:	11/28/2018
Inscription estimée soumise:	01/15/2019
Première publication:	01/17/2019
Dernière mise à jour soumise:	02/02/2020
Dernière mise à jour publiée:	02/04/2020
Date de début réelle de l'étude:	06/19/2018
Date d'achèvement primaire estimée:	11/30/2023
Date estimée d'achèvement de l'étude:	11/30/2023

Condition ou maladie

Iris Tumor

Phase

Groupes d'armes

Bras	Intervention / traitement
Iris Tumors 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.
Healthy Controls This group will consist of 50 adults age 18 and older who have healthy eyes.

Critère d'éligibilité

Âges éligibles aux études	18 Years À 18 Years
Sexes éligibles à l'étude	All
Méthode d'échantillonnage	Non-Probability Sample
Accepte les bénévoles en santé	Oui
Critères	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

Résultat

Mesures des résultats primaires

1. Tumor Thickness in Benign vs Malignant Iris Lesions [6 months]

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.

Mesures des résultats secondaires

1. Tumor Area in Benign vs Malignant Iris Lesions [6 months]

Tumor area will be measured by OCT/OCTA in mm2 and compared against conventional UBM measurements.

2. Tumor Volume in Benign vs Malignant Iris Lesions [6 months]

Tumor volume will be measured by OCT/OCTA in mm3 and compared against conventional UBM measurements.

3. Effect of Radiation Treatment on Tumor and Surrounding Ocular Structures [6 months after treatment]

Vessel density and tortuosity will both be measured in % occupied by flow pixels on OCT/OCTA.