Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612541
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROP Imaging
Brief Summary:
The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity ROP patients that lead to more informed clinical decision making Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential Furthermore we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions
Detailed Description:
Imaging studies using HH-SECTR will be performed to assess and quantify structural and vascular disease features associated with ROP Weekly HH-SECTR imaging will be performed concurrently with standard-of-care weekly ROP screening No additional treatments will be given to study patients to benefit HH-SECTR imaging eg sedation dilation etc Study patients will primarily be imaged in the NICU but may also be performed under sedation or anesthesia in the operating room concurrent with standard-of-care exams Because this study will evaluate diagnostic features prognostic of ROP progression and severity HH-SECTR imaging will be performed until 45 weeks cessation of ROP screening or first therapeutic intervention whichever comes first Both eyes will undergo HH-SECTR imaging Diagnostic imaging data will be analyzed following each imaging session No experimental data will be used to alter the management of patients from the standard-of-care
Research materials obtained from subjects will include digital HH-SECTR images digital fundus photography images and documented examination timeline as part of the standard-of-care Patient medical records will be used to determine eligibility to participate in the study and will be used as the source documents for following post-examination clinical variables
The duration of the study will be 5 years The study records and information will be indefinitely archived per NIH rules using the methods noted above
Research materials obtained from subjects will include digital HH-SECTR images digital fundus photography images and documented examination timeline as part of the standard-of-care Patient medical records will be used to determine eligibility to participate in the study and will be used as the source documents for following post-examination clinical variables
The duration of the study will be 5 years The study records and information will be indefinitely archived per NIH rules using the methods noted above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None