Normal Eyelid Sensation Distribution

The purpose of this study is to determine normal eyelid sensation distribution using a Cochet-Bonett Aesthesiometer.

Study Overview

• Status: Completed
• Conditions: Normal Eyelid Sensation Distribution
• Intervention / Treatment: Device: Aesthesiometer

Detailed Description

After proper taken consent patients without previous eyelid surgery in the Oculoplastic clinic at Duke Eye Center and Duke Aesthetic Center will be enrolled to test the eyelid sensation distribution using the Cochet-Bonnet aesthesiometer. The aesthesiometer (Luneau ophthalmologie) with a 0.12mm diameter filament was chosen for its ease of use, sensitivity, and safety. This instrument contains a 6 cm long, retractable, flexible monofilament. For any given length, when applied perpendicularly to test surface, the filament will exert a precise pressure before visibly bending. The filament length inversely corresponds to the pressure exerted by the aesthesiometer.

Selection of eyelid laterality will be randomized on the same day of the study. Ipsilateral upper and lower eyelids will be divided in thirds (medial, central and lateral borders) including the margin (fig.2). The eyelid sensation will be tested on every third by applying the tip of the aesthesiometer filament perpendicular to the eyelid skin and tarsal plate until the filament bent slightly. The filament length will be set at 6 cm (longest length) and applied to the test site 3 times. This process will be repeated 3 times and if the patient verbally responded to the 3rd touch, the number 6 will be recorder.

If the patient responded less than 3 of the 3 times, the filament will be shortened by 0.5 cm and the test will be repeated. This process will be continued by shortening the filament 0.5 cm each time, until the patient feels the filament touch 3 of 3 times. This filament length number will be recorded as the touch reading for that time period.

The mean touch thresholds for the various test sites will be compared using a Freidman two-way analysis variant (ANOVA).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Capable and willing to provide consent
• Has been seen for the first time in the Oculoplastic clinic and does not have previous eyelid surgery
• At least 18 years of age

Exclusion Criteria:

• Unable or unwilling to give consent
• Under 18 years of age
• Previous eyelid surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Eyelid; The selection of the laterality of the eyelid will be randomized

Device: Aesthesiometer; The eyelid sensation will be tested on every third by applying the tip of the aesthesiometer filament perpendicular to the eyelid skin and tarsal plate until the filament bent slightly. The filament length will be set at 6 cm (longest length) and applied to the test site 3 times. This process will be repeated 3 times and if the patient verbally responded to the 3rd touch, the number 6 will be recorder. If the patient responded less than 3 of the 3 times, the filament will be shortened by 0.5 cm and the test will be repeated. This process will be continued by shortening the filament 0.5 cm each time, until the patient feels the filament touch 3 of 3 times. This filament length number will be recorded as the touch reading for that time period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eyelids' sensation distribution	1 year

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Michael Richard, MD, Duke Medical Center

Publications and helpful links

General Publications

• McGowan DP, Lawrenson JG, Ruskell GL. Touch sensitivity of the eyelid margin and palpebral conjunctiva. Acta Ophthalmol (Copenh). 1994 Feb;72(1):57-60. doi: 10.1111/j.1755-3768.1994.tb02738.x.
• Lowther GE, Hill RM. Sensitivity threshold of the lower lid margin in the course of adaptation to contact lenses. Am J Optom Arch Am Acad Optom. 1968 Sep;45(9):587-94. doi: 10.1097/00006324-196809000-00003. No abstract available.
• Black EH, Gladstone GJ, Nesi FA. Eyelid sensation after supratarsal lid crease incision. Ophthalmic Plast Reconstr Surg. 2002 Jan;18(1):45-9. doi: 10.1097/00002341-200201000-00007.
• Komiyama O, Wang K, Svensson P, Arendt-Nielsen L, Kawara M, De Laat A. Ethnic differences regarding sensory, pain, and reflex responses in the trigeminal region. Clin Neurophysiol. 2009 Feb;120(2):384-9. doi: 10.1016/j.clinph.2008.11.010. Epub 2008 Dec 24.
• Costas PD, Heatley G, Seckel BR. Normal sensation of the human face and neck. Plast Reconstr Surg. 1994 May;93(6):1141-5. doi: 10.1097/00006534-199405000-00005.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (Estimate): February 11, 2014

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Eyelid sensation, aesthesiometer
• Other Study ID Numbers: Pro00051285

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No