In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions (NCT01993654) | Clinical Trial Compass
TerminatedNot Applicable
In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions
Stopped: Study was terminated due to low recruitment.
United States17 participantsStarted 2011-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. History of previous ocular surgery within last 3 months
✕. History of inflammatory eye diseases within last 3 months