Eyelid PtosesNCT06040671
Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
A study testing Vectra M3 imaging in people with Eyelid Ptoses and Ectropion Eyelids, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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)… Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Eyelid Ptoses, Ectropion Eyelids, Entropion;Eye
- What is being tested?
- Vectra M3 imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 3 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eyelid ptosis
- Eyelid entropion
- Eyelid ectropion
Who cannot join
- Refusal to participate in the study
- Not signing the Informed Consent Form
- Inability/reluctance to cooperate in the study
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Adam Kopecký, MD,PhD,FEBO
About this study
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.
Read the 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.
- Conditions
- Eyelid Ptoses, Ectropion Eyelids, Entropion;Eye
- Being tested
- Vectra M3 imaging
- Keywords
- Vectra M3 device, Eyelid Ptoses, stereo photographic system, eyelid surgery
- Medical subject headings
- Blepharoptosis, Ectropion, Entropion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vectra M3 imagingOther
Study subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lateral canthal hinge surgery patients | Experimental | Patients undergoing lateral canthal hinge surgery will be enrolled in this group. Receives: Other: Vectra M3 imaging |
| Ptosis surgery patients | Experimental | Patients undergoing ptosis surgery will be enrolled in this group. Receives: Other: Vectra M3 imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Periorbital volume measurement
In all patients, the periorbital volume (volume in mm3) will be assessed metrically.
Measured: 6 months
Secondary outcomes (1)
The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications
The suitability (YES/NO) of using the Vectra M 3D Imaging System in other ophthalmological indications will be assessed.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start3 May 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid PtosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study subjects will be divided into two groups.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Kopecký, MD,PhD,FEBO, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040671
- Sponsor's protocol ID
- 28/RVO-FNOs/2021
- Status last verified
- Sep 2023
- First submitted
- 31 Oct 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers; however, the data may be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of the Effect of Oculoplastic Operations Using the Vectra M 3D Imaging System
- ClinicalTrials.gov ID
- NCT06040671
- Acronym / sponsor ID
- 28/RVO-FNOs/2021
- Conditions
- Eyelid Ptoses, Ectropion Eyelids, Entropion;Eye
- Keywords
- Vectra M3 device, Eyelid Ptoses, stereo photographic system, eyelid surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study subjects will be divided into two groups.
| Arm | Type | Receives |
|---|---|---|
| Lateral canthal hinge surgery patients | Experimental | Other: Vectra M3 imagingPatients undergoing lateral canthal hinge surgery will be enrolled in this group. |
| Ptosis surgery patients | Experimental | Other: Vectra M3 imagingPatients undergoing ptosis surgery will be enrolled in this group. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Eyelid ptosis
- Eyelid entropion
- Eyelid ectropion
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Not signing the Informed Consent Form
- Inability/reluctance to cooperate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vectra M3 imagingStudy subjects from both arms will undergo Vectra M3 imaging to evaluate the result of the surgery. | Other | Lateral canthal hinge surgery patients, Ptosis surgery patients |
Primary outcome
Distance between anatomical points on the face
Time frame: 6 months
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)
Periorbital volume measurement
Time frame: 6 months
In all patients, the periorbital volume (volume in mm3) will be assessed metrically.
1 secondary outcome
The possibility to use the Vectra M 3D Imaging System in other ophthalmological indications
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers; however, the data may be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Kopecký, MD,PhD,FEBO principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vectra M3 imaging in people with Eyelid Ptoses and Ectropion Eyelids, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between anatomical points on the face (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.