Clinical trial · Observational
In Vivo Confocal Microscopy Study of Pigmented Conjunctival Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated due to low recruitment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Conjunctival Malignant Melanoma | — | UNRESOLVED | — |
| Nevus | Nevus | ONTOLOGY_EXACT | 0.98 |
| Primary Acquired Melanosis | — | UNRESOLVED | — |
| Racial Melanosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRT III with Non-Contact Cornea Rostock Module | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Nevus
- interventionNames
- Procedure: HRT III with Non-Contact Cornea Rostock Module
- label
- Racial Melanosis
- interventionNames
- Procedure: HRT III with Non-Contact Cornea Rostock Module
- label
- Primary Acquired Melanosis
- interventionNames
- Procedure: HRT III with Non-Contact Cornea Rostock Module
- label
- Malignant Melanoma
- interventionNames
- Procedure: HRT III with Non-Contact Cornea Rostock Module
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Age over 18 years 2. The ability to provide informed consent for enrollment in the study 3. Diagnosis of conjunctival nevus (Group 1 only) 4. Diagnosis of racial melanosis (Group 2 only) 5. Diagnosis or suspicion of primary acquired melanosis (PAM), scheduled for biopsy (Group 3 only) 6. Diagnosis of possible MM scheduled for biopsy (Group 4 only) 7. Confirmed diagnosis of MM based upon clinical and histopathological findings, and have already undergone resection(Group 4 only) 8. Confirmed diagnosis of MM recurrence based upon clinical and histopathological findings(Group 4 only) 9. Clear cornea (Group 5 only) 10. No conjunctival lesions or recent conjunctival diseases(Group 5 only) 11. No recent chemotherapy or radiotherapy(Group 5 only) Exclusion criteria: 1. History of previous ocular surgery within last 3 months 2. History of inflammatory eye diseases within last 3 months 3. Current or history of glaucoma disease and on glaucoma medication 4. Contact lens use within last 3 months 5. Physical inability to cooperate for confocal microscopy 6. Prior history of infectious keratitis within 3 months 7. Suspicion for PAM or malignant melanoma (MM)(Groups 1,2,3) 8. History of PAM or MM(Groups 1,2,3) 9. Histopathology not confirmatory for MM (group 4 only) 10. History of other ocular carcinoma or any recent ocular topical chemotherapy or radiotherapy (Group 5 only) 11. History of cancer elsewhere in the body which is currently under systemic chemotherapy (group 5 only)
References
Publications (0)
Data not yet available