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

NCT02638610 | Unknown

• 1 other identifier: MMC 0110-15
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Blepharoptosis; Blepharochalasis, Superior; Ectropion; Entropion

Outcome Measures

Primary Outcomes (1)

• Changes of periocular skin sensation following eyelid and ocular surface surgeries (expressed in the length of the aesthesiometer's filament in centimeters).

  6 months

Study Arms (1)

Sensation measurement

EXPERIMENTAL

patients with eyelid pathology going through eyelid surgery.

Device: Cochet-Bonnet aesthesiometer

Interventions

Cochet-Bonnet aesthesiometer DEVICE

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.

Sensation measurement

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give consent
• Eyelid pathology: blepharoptosis, blepharochalasis, ectropion or entropion, with no additional eyelid pathology

You may not qualify if:

• Children and pregnant women
• Previous eyelid surgery
• A systemic disease influencing eyelid position
• Any neurologic disease
• Previous facial herpetic infection

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Blepharoptosis; Blepharochalasis, Superior; Ectropion; Entropion

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Central Study Contacts

Tal Koval, MD

CONTACT

972-54-7772874; talkovalr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 23, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: January 1, 2017
• Last Updated: December 23, 2015

Record last verified: 2015-12