NCT00346372

Brief Summary

During regularly scheduled appointments, Optical Coherence Tomography (OCT) is performed on consented subjects. The OCT is a new type of camera that takes very detailed pictures inside of the eye and deeper into eye tissues. Optical Coherence Tomography imaging of intraocular tumors may lead to improved diagnosis and monitoring of tumors within the eye.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2017

Completed
Last Updated

August 12, 2019

Status Verified

January 1, 2018

Enrollment Period

13.8 years

First QC Date

June 27, 2006

Last Update Submit

August 8, 2019

Conditions

Keywords

Ocular MelanomaOptical Coherence TomographyEye TumorChoroidal MelanomaUveal Melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who meet the following Eligibility Criteria

You may qualify if:

  • Adults (18 years or older) with:
  • choroidal nevus greater than or equal to 3.0 mm in longest basal diameter, or greater than or equal to 1.25 mm in apical height or:
  • choroidal melanoma located in the posterior pole (4mm or less from the center of fovea or the border of the optic nerve head)

You may not qualify if:

  • Ocular media opacity in the tumor eye that prevents adequate functional testing or imaging and prior or concurrent retinal or choroidal disease in the tumor eye that prevents adequate functional testing or imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Uveal MelanomaEye Neoplasms

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Study Officials

  • Bradley R Straatsma, MD, JD

    Jules Stein Eye Institute, UCLA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 29, 2006

Study Start

March 1, 2004

Primary Completion

November 27, 2017

Study Completion

November 27, 2017

Last Updated

August 12, 2019

Record last verified: 2018-01

Locations