Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System

NCT06040671 | Unknown

• 1 other identifier: 28/RVO-FNOs/2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

An objective assessment of that part of the spectrum of ophthalmic eyelid surgeries that focuses on correcting the position of entropy (e.g. 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.

Conditions

Eyelid Ptoses; Ectropion Eyelids; Entropion;Eye

Keywords

Vectra M3 device; Eyelid Ptoses; stereo photographic system; eyelid surgery

Outcome Measures

Primary Outcomes (2)

• Distance between anatomical points on the face

  In all patients, distance between 52 anatomical-topographical points on the face will be measured in millimetres (mm) - change of the position of the eyelids before and after surgery (distance in mm), the relation of the eyelids to the periorbital landscape (distance in mm)

  6 months

• Periorbital volume measurement

  In all patients, the periorbital volume (volume in mm3) will be assessed metrically.

  6 months

Secondary Outcomes (1)

• The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications

  3 years

Study Arms (2)

Lateral canthal hinge surgery patients

EXPERIMENTAL

Patients undergoing lateral canthal hinge surgery will be enrolled in this group.

Other: Vectra M3 imaging

Ptosis surgery patients

EXPERIMENTAL

Patients undergoing ptosis surgery will be enrolled in this group.

Other: Vectra M3 imaging

Interventions

Vectra M3 imaging OTHER

Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.

Lateral canthal hinge surgery patients; Ptosis surgery patients

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eyelid ptosis
• Eyelid entropion
• Eyelid ectropion

You may not qualify if:

• Refusal to participate in the study
• Not signing the Informed Consent Form
• Inability/reluctance to cooperate in the study

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

MeSH Terms

Conditions

Blepharoptosis; Ectropion; Entropion

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Adam Kopecký, MD,PhD,FEBO

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking is used in the study.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be divided into two groups.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: September 15, 2023
• Study Start: May 3, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)