Retrospective Case Series of Trans-scleral Cryotherapy for Retinal Hemangioblastoma

Active, not recruiting

• Conditions: Retinal Hemangioblastoma; Von Hippel-Lindau Disease

• Registration Number: NCT04458935
• Lead Sponsor: National Eye Institute (NEI)

Brief 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....

Detailed 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).

Study Timeline

• Study Start: 2020-07-02
• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-07
• Status Verified: 2025-03-12
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To perform a retrospective analysis of consecutive cases of retinal hemangioblastoma (RH) managed with trans-scleral cryotherapy at the NIH	ongoing	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.

Trial Locations

Locations (1)

National Eye Institute (NEI); 🇺🇸 Bethesda, Maryland, United States