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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02638610
Other study ID # MMC 0110-15
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 16, 2015
Last updated December 22, 2015
Start date January 2016
Est. completion date January 2017

Study information

Verified date December 2015
Source Meir Medical Center
Contact Tal Koval, MD
Phone 972-54-7772874
Email talkovalr@gmail.com
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

The aim of the study: Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries.

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date January 2017
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Ability to give consent

- Eyelid pathology: blepharoptosis, blepharochalasis, ectropion or entropion, with no additional eyelid pathology

Exclusion Criteria:

- Children and pregnant women

- Previous eyelid surgery

- A systemic disease influencing eyelid position

- Any neurologic disease

- Previous facial herpetic infection

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Device:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of periocular skin sensation following eyelid and ocular surface surgeries (expressed in the length of the aesthesiometer's filament in centimeters). 6 months No
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