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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04458935
Other study ID # 999920129
Secondary ID 20-EI-N129
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2, 2020
Est. completion date June 30, 2024

Study information

Verified date February 9, 2024
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Retinal hemangioblastoma (RH) is a tumor. It grows from the retina in the eye. It can threaten a person s vision. Trans-scleral cryotherapy is used to destroy the tumors and minimize the long-term risks of vision loss. RH is a rare condition, often occurring in people with von Hippel-Lindau disease. There are no clinical trials to study how well the treatment works. Researchers want to study the medical records of people with RH who were treated at the NIH eye clinic to learn more. Objective: To analyze clinical data collected over a 20-year span to study consecutive cases of RH managed with trans-scleral cryotherapy at the NIH. Eligibility: People who took part in NIH natural history protocols for which cryotherapy of RH was performed as a standard care measure. Design: Researchers will collect and study data from participants medical charts. Participants will not be contacted because no new data is needed. Researchers were granted a waiver of informed consent for use of these medical records. To protect patient privacy, participants will be assigned an ID number. Their data will be entered into a spreadsheet in a coded fashion. The key to this code will be kept in a secure file. No patient identifying information will be used in the analysis or the publication....


Description:

Study Description: This study is a retrospective review of medical records in the NIH eye clinic. To our knowledge, there has been no report in the current era dedicated to a description of trans-scleral cryotherapy for retinal hemangioblastomas despite its routine use in this setting. This study aims to explore features and outcomes of these cases to better inform best practices. Objectives: The objective of this study is to perform a retrospective analysis of consecutive cases of retinal hemangioblastoma managed with trans-scleral cryotherapy at the NIH (single center retrospective case series).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 120 Years
Eligibility - INCLUSION CRITERIA: 1. Participants were enrolled in NEI and non-NEI natural history protocols, but in all cases, cryotherapy was administered as a standard care measure (not as an investigative treatment). 2. Patients were identified by searching the NIH eye clinic EMR for all of those manifesting one or more retinal hemangioblastomas (with or without associated von Hippel-Lindau disease) treated with cryotherapy. EXCLUSION CRITERIA: None

Study Design


Locations

Country Name City State
United States National Eye Institute (NEI) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To perform a retrospective analysis of consecutive cases of retinal hemangioblastoma (RH) managed with trans-scleral cryotherapy at the NIH Some key measures of interest will include treatment outcomes (rate of control of tumors; visual function measures; post-treatment lesion characteristics; sequelae and complications) and association of outcomes with eye and lesion characteristics. ongoing
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