Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06040671
Status:
RECRUITING
Last Update Posted:
2023-09-15
First Post:
2022-10-31
Brief Title:
Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An objective assessment of that part of the spectrum of ophthalmic eyelid surgeries that focuses on correcting the position of entropy eg ectropion ptosis surgery is very difficult - although it is possible to use different measuring parameters distance of pupillary reflexes from the edges of the eyelid comparing different distances on the face exophthalmometry or the lid laxity test - the so-called snap-back test but all these methods are based either on the subjective assessment of the examiner or on the correctness of the attached ruler and their objectivity is therefore very low
Detailed Description:
The goal of the project is to develop a methodology for evaluating the results of operations using a stereo photographic system to objectively evaluate the functionality and results of various eyelid operations and subsequently to expand the use of the device in other ophthalmological indications
Different files will be created where the effect of different operations will be monitored in parallel
Lateral canthal hinge surgery will be evaluated in the pilot group and ptosis surgery through an anterior approach will be evaluated in the second group
In all patients the position of the eyelids their change before and after surgery the periorbital volume and the relation of the eyelids to the periorbital landscape will be assessed metrically
The Vectra M3 device will be used for the measurement
The expected cohort size is 40 patients in each group
Different files will be created where the effect of different operations will be monitored in parallel
Lateral canthal hinge surgery will be evaluated in the pilot group and ptosis surgery through an anterior approach will be evaluated in the second group
In all patients the position of the eyelids their change before and after surgery the periorbital volume and the relation of the eyelids to the periorbital landscape will be assessed metrically
The Vectra M3 device will be used for the measurement
The expected cohort size is 40 patients in each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None