In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions

Stopped early

Conditions studied: Nevus, Racial Melanosis, Primary Acquired Melanosis, Conjunctival Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT01993654

Run by

Massachusetts Eye and Ear Infirmary

People needed

17

Starts

2011-09-01

Expected to finish

2015-07-01

Last updated by the study team

2016-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• History of previous ocular surgery within last 3 months
• History of inflammatory eye diseases within last 3 months
• Current or history of glaucoma disease and on glaucoma medication
• Contact lens use within last 3 months
• Physical inability to cooperate for confocal microscopy
• Prior history of infectious keratitis within 3 months
• Suspicion for PAM or malignant melanoma (MM)(Groups 1,2,3)
• History of PAM or MM(Groups 1,2,3)
• Histopathology not confirmatory for MM (group 4 only)
• History of other ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy (Group 5 only)
• History of cancer elsewhere in the body which is currently under systemic chemotherapy (group 5 only)

Where it is running

• Massachusetts Eye & Ear Infirmary — Boston, Massachusetts, United States
• Wills Eye Hospital — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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