Detection of Choroidal Nevus Cells in Vitrectomy Fluid

Nevus Clinical Trial

Official title:

Detection of Choroidal Nevus Cells in Vitrectomy Fluid

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01324609
• Other study ID #: SU-03242011-7564
• Secondary ID: IRB-18580
• Status: Terminated
• Start date: June 2010
• Est. completion date: May 2013

Study information

• Verified date: July 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if the investigators can detect the presence of choroidal nevi cells in the vitreous fluid of humans, as this may improve the diagnosis and classification of choroidal nevi and melanomas in the future.

Description:

Approximately 7% of the population has a choroidal nevus, or "freckle," in the back of the eye. Like a nevus on the skin, there is potential for malignant change to a melanoma. Dermatologists have the ability to quickly and easily biopsy suspicious skin lesions while ophthalmologists currently have no way of determining the malignant potential of choroidal nevi other than a fine needle aspiration (which is invasive and has the potential complications of bleeding and retinal detachment). This study's sole aim is to see if choroidal nevi cells are present in the inside fluid of the eye. The investigators plan to analyze the fluid of the eye, which is routinely removed during retina surgery, to detect any nevus cells. If the investigators are able to detect these cells, then future studies may allow us to better classify choroidal nevi for potential malignant change.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a choroidal nevus who are undergoing routine vitrectomy surgery for another indication (such as epiretinal membrane or macular hole repair).

Exclusion Criteria:

• Patients without a choroidal nevus

• Children under the age of 18

• Pregnant and nursing females

Related Conditions & MeSH terms

• Nevus

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive identification of nevus cells in eye fluid		1 day