Normal Eyelid Sensation Distribution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-06-30

Brief Summary

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

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Detailed Description

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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).

Conditions

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Normal Eyelid Sensation Distribution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Eyelid

The selection of the laterality of the eyelid will be randomized

Group Type EXPERIMENTAL

Aesthesiometer

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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