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The study was terminated.
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Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and after an intervention (such as a dry eye treatment, environmental change, artificial tear use, or contact lens wear) in a controlled-environmental chamber, over time using non-contact instruments.
Most studies will set the environmental conditions (temperature, humidity, airflow) to mimic typical office and home environments (68 to 72F and 20 to 50%). For condition change studies, the chamber will operate between 65 and 85F and 25% and 80% RH with air flow turned off or set to a maximum of 3-4 m/s. For this type of study we will have the subject acclimate to a set of environmental conditions (approximately 20 minutes) and take a set of measurements. Then we will change the conditions (rate of change is 3F/hour and 3% RH/hour), have the subject acclimate to these conditions (later on the same day or on another day) and take another set of measurements. The expected study length is approximately two hours for a single visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | Experimental | Subjects with no clinical diagnosis or symptoms of dry eye. |
|
| Aqueous Deficiency Dry Eye (ADDE) | Experimental | Subjects with low tear volume measured by Schirmer's test less than 10 mm. |
|
| Meibomian Gland Dysfunction (MGD) | Experimental | Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Environmental Chamber Condition Change Intervention | Other | For condition change studies, the chamber will operate between 65 and 85 degrees F and 25% and 80% RH with air flow turned off or set to a maximum of 3-4 m/s. For this type of study, we will have the subject acclimate to a set of environmental conditions (approximately 20-30 minutes) and take a set of measurements. Then we will change the conditions (rate of change is 3 degrees F/hour and 3% RH/hour), have the subject acclimate to these conditions (later on the same day or on another day) and take another set of measurements. The expected study length is approximately two hours for a single visit. Subjects may be asked to return for additional visits to accommodate a variety of chamber conditions (temp, humidity, airflow) within the prescribed limits above. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular Surface Temperature (OST) | Objectively evaluate the ocular surface temperature prior to and after 30 minutes of acclimation to three different environmental conditions in a controlled-environmental chamber using thermal imaging. 10 eyes were analyzed for each group. | baseline and 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Individuals with eye or medical condition(s) that contraindicate performing screening or measurements will not be eligible for this study. Specific examples include:
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| Name | Affiliation | Role |
|---|---|---|
| James V Aquavella, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flaum Eye Institute at the University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal | Subjects with no clinical diagnosis or symptoms of dry eye. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity. |
| FG001 | Aqueous Deficiency Dry Eye (ADDE) | Subjects with low tear volume measured by Schirmer's test less than 10 mm. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity. |
| FG002 | Meibomian Gland Dysfunction (MGD) | Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nominal Condition |
| |||||||||||||
| Low Humidity Condition |
| |||||||||||||
| High Temperature Condition |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal | Subjects with no clinical diagnosis or symptoms of dry eye. |
| BG001 | Aqueous Deficiency Dry Eye (ADDE) | Subjects with low tear volume measured by Schirmer's test less than 10 mm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Ocular Surface Temperature (OST) | Objectively evaluate the ocular surface temperature prior to and after 30 minutes of acclimation to three different environmental conditions in a controlled-environmental chamber using thermal imaging. 10 eyes were analyzed for each group. | Posted | Mean | Standard Deviation | degree celsius | baseline and 30 minutes | eyes | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal | Subjects with no clinical diagnosis or symptoms of dry eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James V. Aquavella | University of Rochester | 585-275-8944 | james_aquavella@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Meibomian Gland Dysfunction (MGD) | Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Meibomian Gland Dysfunction (MGD) |
Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Aqueous Deficiency Dry Eye (ADDE) | Subjects with low tear volume measured by Schirmer's test less than 10 mm. | 0 | 6 | 0 | 6 |
| EG002 | Meibomian Gland Dysfunction (MGD) | Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. | 0 | 6 | 0 | 6 |
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