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NCT01993654 · ClinicalTrials.gov registry record
In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions
A clinical trial, sponsored by Massachusetts Eye and Ear Infirmary.
- Terminated
- Registry status
- 17
- Enrollment target
NCT01993654: Clinical Trial study, sponsored by Massachusetts Eye and Ear Infirmary.
NCT01993654 is a clinical trial that was terminated before completion, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01993654 was terminated before completion, sponsored by Massachusetts Eye and Ear Infirmary.
- TERMINATED
- Registry status
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
Heidelberg Retina Tomography (HRT) and Optical Coherence Tomography (OCT) will be used to measure pigmented conjunctival lesions. (HRT) is performed with a confocal scanning laser ophthalmoscope. Along with corneal analysis software, the HRT is able to image cells and cell layers within the cornea. Optical Coherence Tomography (OCT) is a noninvasive optical imaging modality analogous to an ultrasound B-scan. OCT images will be used to estimate tumor depth. Immunohistochemistry results will be r
Interventions
- PROCEDURE HRT III with Non-Contact Cornea Rostock Module
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-07 |
Why NCT01993654 stopped before completion
NCT01993654 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which HRT III with Non-Contact Cornea Rostock Module is the first listed.
NCT01993654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01993654 about?
NCT01993654 is a clinical study titled "In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions". 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 re...
What is the current status of trial NCT01993654?
This trial is currently terminated. The enrollment target is 17 participants. The study started on 2011-09. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01993654?
The interventions under investigation include: HRT III with Non-Contact Cornea Rostock Module (PROCEDURE).
Who is sponsoring clinical trial NCT01993654?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
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