Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries
NCT ID: NCT02638610
Last Updated: 2015-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-01-31
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Study design: an interventional study that will be conducted at the ophthalmology department, Meir hospital, Kfar Saba, Israel.
the study will include 60 healthy patients, at the ages of 40-80, which are candidates for eyelid surgery: blepharoptosis repair, blepharoplasty, ectropion repair and entropion repair.
The patients will be recruited from Meir's ophthalmology outpatient clinic. Each patient will undergo a full ophthalmologic examination including relevant assessment of the specific eyelid pathology.
The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet filament-type aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take place before surgery, and two weeks, three months and six months after surgery.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sensation measurement
patients with eyelid pathology going through eyelid surgery.
Cochet-Bonnet aesthesiometer
The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take place before surgery, and two weeks, three months and six months after surgery.
This instrument contains a 6 centimeters long, retractable, flexible monofilament. For any given length, when applied perpendicularly to a test surface, the filament will exert a precise pressure before visibly bending. The filament's length inversely corresponds to the pressure exerted by the aesthesiometer such that the shorter the filament length, the more pressure it exerts on the test surface.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cochet-Bonnet aesthesiometer
The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take place before surgery, and two weeks, three months and six months after surgery.
This instrument contains a 6 centimeters long, retractable, flexible monofilament. For any given length, when applied perpendicularly to a test surface, the filament will exert a precise pressure before visibly bending. The filament's length inversely corresponds to the pressure exerted by the aesthesiometer such that the shorter the filament length, the more pressure it exerts on the test surface.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Eyelid pathology: blepharoptosis, blepharochalasis, ectropion or entropion, with no additional eyelid pathology
Exclusion Criteria
* Previous eyelid surgery
* A systemic disease influencing eyelid position
* Any neurologic disease
* Previous facial herpetic infection
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Meir Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MMC 0110-15
Identifier Type: -
Identifier Source: org_study_id