We Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface. Clinical Trial
| Verified date | January 2014 |
| Source | Hallym University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Tear film consists of three layers including outer lipid layer, aqueous layer and inner mucin
layer.1,2 Lipid layer protects the aqueous layer of tear film from evaporation and mucin
layer adhere the tear film to ocular surface. Aqueous layer, which is produced in lacrimal
glands, is the most important in the health of ocular surface. Reduction of aqueous tear
secretion results in the disruption of homeostasis at ocular surface and leads to dry eye
syndrome.2 Dry eye syndrome is a common ocular surface disease associated with symptoms of
eye discomfort, grittness and visual disturbance.1,2 Dry eye syndrome disrupts normal
homeostasis at the ocular surface resulting in epithelial damage, epithelial cell apoptosis,
loss of goblet cells, and squamous metaplasia.1-3 The changes and inflammation of ocular
surface subsequently lead to tear instability, which causes an increased tear osmolarity and
aggravates the inflammatory cascades. This leads to a vicious cycle.2 The regulation of tear
film secretion is under neural and hormonal control.4 Dry eye syndrome has been associated
with diverse and multiple causes, including depressive disorder, drugs, hormonal status, and
systemic diseases.2 Sleep deprivation (SD) is known to cause profound impair¬ments in
executive function and vigilant attention.5,6 It is also reportedly associated with autonomic
and endocrine functioning7-9 and has been shown to increase blood pressure and stress hormone
levels and decrease parasympathetic tone.10,11 Tear secretion is regulated by neurological
factors and hormones,12 and so SD may have an effect on the tear film and ocular surface.
However, only a few studies have evaluated the effect of sleep on the tear film and ocular
surface.
In this study, we investigated the effect of SD on the tear film and ocular surface.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 20 Years to 30 Years |
| Eligibility |
Inclusion Criteria: - Twenty healthy young male volunteers aged 20-30 years Exclusion Criteria: - •Subjects with dry eye symptoms within the previous 6 months were excluded from the study. - Subjects have any systemic diseases such as systemic lupus, rheumatoid arthritis, Sjögren's syndrome or a history of ocular disease. - Subjects have disorder of lid margin, nasolacrimal duct, and cornea. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Hallym University, Kangnam Sacred Heart Hospital | Seoul, |
| Lead Sponsor | Collaborator |
|---|---|
| Hallym University Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tear osmolarity measurement | A microcapillary glass tube (Marienfeld, Lauda-Königshofen, Germany) was placed on the lower outer conjunctival sac. To avoid reflex tearing, the subjects were asked to direct their gaze supranasally. A total of 30 µL of tears was taken from the marginal tear strip. After centrifugation at 3000 rpm for 3 min, supernatants were obtained and the samples were stored at -80 degree. Tear osmolarity was measured using a Multi-OSMETTE 2430 (Precision Systems Inc., Natick, MA, USA). | 1 day | |
| Secondary | Visual analog pain score | Visual analog pain score Subjective discomfort or pain was graded numerically using the VAS. The scale range was 0 (absence of pain) to 10 (maximal pain). Subjects were asked to describe their symptoms using the VAS. | 1 day | |
| Secondary | Tear break up time | Fluorescein was placed in the lower conjunctival sac using a fluorescein strip (HAAG-STREIT, Köniz, Switzerland), and the time between the last blink and the first appearance of a dark spot was measured using the cobalt blue light of a slit lamp. This procedure was repeated 3 times, and the average value was recorded. | 1 day | |
| Secondary | Intraocular pressure | Intraocular pressure was measured by noncontact tonometer (CT-80, Topcon Corp., Tokyo, Japan). Intraocular pressure expressed in millimeters of mercury (mm Hg). | 1 day | |
| Secondary | Schirmer's test | One drop of 0.5% proparacaine hydrochloride (Alcaine, Alcon, Forth Worth, TX, USA) was instilled in the conjunctival sac for topical anesthesia. In a silent room, filter paper (Color Bar, EagleVision, Memphis, TN, USA) was placed in the inferolateral one-third of the lower lid. Care was taken to prevent the paper from contacting the cornea. After 5 minutes, the level of strip wetting (in millimeters) was measured. | 1 day |