Clinical trial NCT04458935: Retrospective Case Series of Trans-scleral Cryotherapy for Retinal Hemangioblastoma
Official title: Retrospective Case Series of Trans-scleral Cryotherapy for Retinal Hemangioblastoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Retinal Hemangioblastoma
Von Hippel-Lindau Disease
Keywords: Vascular Tumor
Vision Loss
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-07-07
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data (medical history and images) was collected under NEI and non-NEI natural history protocols allowing administration of standard care measures to participants.

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).

Eligibility criteria: * 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

Primary outcomes:
measure: To perform a retrospective analysis of consecutive cases of retinal hemangioblastoma (RH) managed with trans-scleral cryotherapy at the NIH
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Eye Institute (NEI)
state: Maryland
Study officials:
affiliation: National Eye Institute (NEI)
name: Emily Y Chew, M.D.
role: PRINCIPAL_INVESTIGATOR
References: