In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions

Status: Terminated
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

This study aims to validate the use of laser in vivo confocal microscopy as an early diagnostic and differentiation tool of pigmented conjunctival lesions, evaluate the efficacy of in vivo confocal microscopy for follow-up (as a visualizing tool) after tumor resection for early detection of tumor recurrence, and to evaluate the use of in vivo confocal microscopy in evaluation of response to treatment. The modified technique with Heidelberg Retina Tomography (HRT) confocal microscopy and anterior segment optical coherence tomography (OCT) are non-invasive, no-touch, imaging techniques that may help in differentiation of benign lesions like nevi or racial melanosis, from malignant lesions like primary acquired melanosis and malignant melanomas. The OCT will potentially allow to estimate tumor depth in vivo as preliminary studies have shown.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Age over 18 years

• The ability to provide informed consent for enrollment in the study

• Diagnosis of conjunctival nevus (Group 1 only)

• Diagnosis of racial melanosis (Group 2 only)

• Diagnosis or suspicion of primary acquired melanosis (PAM), scheduled for biopsy (Group 3 only)

• Diagnosis of possible MM scheduled for biopsy (Group 4 only)

• Confirmed diagnosis of MM based upon clinical and histopathological findings, and have already undergone resection(Group 4 only)

• Confirmed diagnosis of MM recurrence based upon clinical and histopathological findings(Group 4 only)

• Clear cornea (Group 5 only)

• No conjunctival lesions or recent conjunctival diseases(Group 5 only)

• No recent chemotherapy or radiotherapy(Group 5 only)

Locations
United States
Massachusetts
Massachusetts Eye & Ear Infirmary
Boston
Pennsylvania
Wills Eye Hospital
Philadelphia
Texas
MD Anderson Cancer Center
Houston
Time Frame
Start Date: September 2011
Completion Date: July 2015
Participants
Target number of participants: 17
Treatments
Nevus
Racial Melanosis
Primary Acquired Melanosis
Malignant Melanoma
Normal
Sponsors
Leads: Massachusetts Eye and Ear Infirmary
Collaborators: M.D. Anderson Cancer Center, Wills Eye

This content was sourced from clinicaltrials.gov

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