Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries

Blepharoptosis Clinical Trial

Official title:

Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02638610
• Other study ID #: MMC 0110-15
• 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

Related Conditions & MeSH terms

• Blepharochalasis, Superior
• Blepharoptosis
• Ectropion
• Entropion

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