Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 20 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | June 2010 |
| End Date: | December 2011 |
Non-invasive Tear Film Dynamic Measurements in Normal, MGD (Meibomium Gland Dysfunction) and Aqueous Deficient Dry Eye(ADDE) Subjects After Saline Instillation
Compare the objective tear film dynamic measurements in three different populations (MGD
[Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry
eye]) and the subjective experience before and after instilling a single drop of saline in
each eye.
Currently available office-based tests for dry eye do not reliably correlate with patients'
subjective symptoms. This study is interested in assessing how individuals with these two
different ocular surface diseases compare with the normal population when measured
objectively using two different instruments.
[Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry
eye]) and the subjective experience before and after instilling a single drop of saline in
each eye.
Currently available office-based tests for dry eye do not reliably correlate with patients'
subjective symptoms. This study is interested in assessing how individuals with these two
different ocular surface diseases compare with the normal population when measured
objectively using two different instruments.
There will be one study day with a single visit that will consist of taking two sets of
measurements. Baseline measurements are taken in both eyes using a wavefront sensor to
measure visual quality followed by saline instillation. Five minutes after drops, visual
quality is again measured to evaluate changes in tear dynamics.
measurements. Baseline measurements are taken in both eyes using a wavefront sensor to
measure visual quality followed by saline instillation. Five minutes after drops, visual
quality is again measured to evaluate changes in tear dynamics.
General Inclusion Criteria:
- Good general Health
- The subject must appear able and willing to adhere to the instructions set forth in
this protocol (such as not use warm compresses or artificial tears/lubricant or
excessive eye makeup before the visit on the study day).
General Exclusion Criteria:
- Ocular disease, infection or inflammation (allergy, blepharitis) that is clinically
significant (grade 3 or 4) that in the opinion of the PI would not be a good subject.
- Systemic disease or use of medication that in the opinion of the PI would not be a
good subject.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease
(e.g. HIV).
- Contact lens wearer.
- Pregnancy or lactation.
- Diabetes.
- Inclusion or exclusion criteria of the other cohorts.
Cohort Specific Inclusion Criteria:
- ADDE cohort: Schirmer I < 10 mm, BUT ¬< 5 seconds, Fluorescein 0 or 1, currently
using an artificial tear for ocular comfort at least occasionally.
- MGD cohort: Diagnosis of moderate or severe MGD
- Normal/Control (Non Dry-Eye): meets general inclusion and exclusion criteria
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