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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02638610

Enrollment

Registered

2015-12-23

Start date

2016-01-31

Completion date

2017-01-31

Last updated

2015-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharochalasis, Superior, Blepharoptosis, Ectropion, Entropion

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.

Interventions

DEVICECochet-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes of periocular skin sensation following eyelid and ocular surface surgeries (expressed in the length of the aesthesiometer's filament in centimeters).	6 months

Contacts

Primary ContactTal Koval, MD

talkovalr@gmail.com972-54-7772874

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026