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Understanding the pathogenesis of eye diseases has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems, such as optical coherence tomography (OCT), are limited in terms of resolution, acquisition speed or access to certain eye functions. Our team has participated in the development of a new generation of imaging technology known as optical transmission tomography (OTT), which enables imaging of the anterior parts of the eye with high cellular resolution, a wide field of view and reduced examination delay.
For healthy subjects: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out twice, at an interval of two (2) years (inclusion visit + visit at 24 months). Several imaging images will be taken by two different operators during these sessions.
For patients: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken. These examinations will be carried out at the inclusion visit and at the following visits according to the disease assessment schedule, lasting up to a maximum of 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Ocular Disease | Experimental | Patients: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken from different positions. These examinations will be performed at the inclusion visit and at follow-up visits as part of the usual management of the disease up to a maximum of 4 years |
|
| Healthy volunteers | Active Comparator | Healthy Volunteers: an imaging examination by each system (OTT + OCT + specular microscopy) will be carried out twice, at the inclusion visit and at 24 months (2 years), the maximum duration of participation for healthy volunteers. Several imaging sessions will be carried out by two different operators at different positions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Transmission Tomography (OTT) | Device | Multiple imaging sessions added by research using the systems described (OTT) will be carried out by two different operators at different positions during these sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Image quality | Quality assessed by two blinded experts. This is an evaluation of image quality in terms of operation according to the following scheme. Quality assessment: - Sufficient quality : Yes Or No If no, tick yes, below and fill in the cause: Insufficient quality: ☒ yes ☐ no Cause:
| between 1 day and 4 years |
| Endothelial cell density | Assessment of endothelial cell density. | between 1 day and 4 years |
| Imaging new corneal and lens structures | corneal and lens structures:measure density in other cell types | between 1 day and 4 years |
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Inclusion Criteria:
For Patients:
For Healthy volunteers:
Exclusion Criteria:
For all participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabil BROUK | Contact | 00 33 1 40 02 11 44 | nbrouk@15-20.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nacim BOUHERAOUA, PU-PH | Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Recruiting | Paris | 75012 | France |
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Prospective, exploratory, longitudinal, non-randomized, single-center study including patients and healthy volunteers.
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| Optical Coherence Tomography (OCT) | Device | Multiple imaging sessions (OCT) already used in standard of care will be performed by two different operators at different positions during these sessions. |
|
| Specular Microscopy (SM) | Device | Multiple imaging sessions (SM) already used in standard of care will be performed by two different operators at different positions during these sessions. |
|
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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