Dry Eye
Conditions
Keywords
dry eye, tear film, thickness, artificial tears
Brief summary
The aim of this investigation is to determine the thickness of the human preocular tear film using a new method based on laser speckle. This will be a preliminary study to generate normative tear film thickness data in normal (i.e., non dry eye) and dry eye subjects in a clinic-based population. In addition, we will examine the short term (i.e., one week) repeatability of the method in a single setting. The patients classified as having dry eye will also have their tear film thickness measured after instillation of an artificial tear. This will potentially reveal valuable data in retention of effect measured non-invasively as in prior studies that employed a fluorescein tracer.
Detailed description
We will generate normative tear thickness data in normal (i.e., not dry) and dry eyes in human subjects. We will examine short-term repeatability of the method, and we will examine the influence on tear thickness of a viscous eyedrop instilled into the eye.
Interventions
None listed
Sponsors
Southern California College of Optometry at Marshall B. Ketchum University
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
There are no requirements as to subject race, gender or occupation. If the subjects have any questions or concerns regarding any of the inclusion or
Exclusion criteria
, they will be encouraged to ask either investigator (Dr. Paugh or Dr. Kwan) for clarification. All subjects must meet the following criteria: 1. The informed consent document must be read, signed and dated by the subject before conducting any procedures. Additionally, the informed consent document must be signed and dated by the individual obtaining consent of the subject. HIPAA authorization must also be signed and dated by the subject. 2. Adult subjects, 18 years of age and older. Criteria for the mild to severe dry eye group must include two of the three following characteristics as demonstrated at the Eligibility visit: 1. Composite symptom score of ≥ 7 on the Schein questionnaire: 2. Sodium fluorescein (NaFl) tear break-up time ≤ 7 seconds in either (worse) eye 3. Cumulative sodium fluorescein (NaFl) corneal staining ≥ 4 in either (worse) eye on a 0-20 point scale (corresponds to ≥ 3.0 on a 0-15 scale). 3. Able and willing to follow study instructions. 4. Willing to return for the repeatability visit within 7 plus or minus 2 days of the initial visit, and within the same one-half day (i.e., either in the morning or afternoon, similar to the first tear thickness visit). 5. Subjects must have best corrected visual acuity of 20/25 or better in each eye as assessed using a standard Snellen acuity chart. 6. Subjects wearing soft contacts lenses must be willing to discontinue wear for two days before each study visit. 7. Subjects using any topical drops such as artificial tears must be willing to discontinue use of such drops for two days prior to all visits, including the baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear film thickness in normal eyes | 1-3 months |
Secondary
| Measure | Time frame |
|---|---|
| Tear thickness change following viscous drop instillation | 1-3 months |
Countries
United States
Outcome results
None listed