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Principle investigator changed practice location and discontinued study
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purpose is to compare the prevalence of dry eyes in diabetics and non diabetics. This might help identify a group of patients at greater risk for dry eye complications. Diabetics have been shown to have poor ocular surface healing and might benefit from dry eye therapy earlier if they are shown to be at greater risk for dry eyes.
Dry eye disease is one of the most common eye problems seen in ophthalmology. Diabetics are at high risk for multiple eye problems, including retinopathy and glaucoma. They also have been shown to have poor ocular surface healing. I would like to evaluate the prevalence of dry eye disease in diabetics to see if they are also at greater risk for the known complications of dry eye disease. If so, they might benefit from early intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diabetics | diabetics | ||
| non diabetics | non diabetics |
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| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Staining Score | Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining. | at the time of the evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Film Osmolarity | The tear film osmolarity is measured at the time of the exam. | at the time of the exam |
| Measure | Description | Time Frame |
|---|---|---|
| OSDI Score | The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability. | at the time of the exam |
| Schirmer Score |
Inclusion Criteria:
Exclusion Criteria:
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Existing clinic population from our practice
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth A Beckman, MD | COA Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbus Ophthalmalogy Associates | Columbus | Ohio | 43213 | United States |
Being that there was no intervention and the study only involved taking measurements at the time of the exam, there was no transition required. Any eligible patient that was willing to participate was included. Consecutive diabetic patients and consecutive non-diabetic patients that met criteria were offered the opportunity to enroll.
Subjects were enrolled randomly. Consecutive patients in a private ophthalmology clinic that met inclusion criteria were asked to participate at the time of an already scheduled exam. The non-diabetic group recruitment stopped once the target number of subjects enrolled. The diabetic group recruitment continued until the study was terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetics | diabetics over age 40 |
| FG001 | Non Diabetics | non diabetics over age 40 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetics | diabetics over age 40 |
| BG001 | Non Diabetics | non diabetics over age 40 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Conjunctival Staining Score | Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining. | There were 38 consecutive diabetics over 40 years of age and 25 consecutive non-diabetics over 40 years of age that qualified and agreed to enroll. A target of 25 non-diabetics was met. The target of 50 was not met as the study was stopped when the PI changed practices. By that time, 38 diabetics enrolled. | Posted | Mean | Standard Error | units on a scale | at the time of the evaluation | 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 | Diabetics | diabetics over age 40 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth A Beckman, MD | Coa Research Foundation | 614-506-4720 | kenbeckman22@aol.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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The schirmer tear production test with anesthesia is completed at the time of the exam in mm of tear film absorption on the test strip after five minutes. Higher scores represent greater tear production.
| at the time of the exam |
| Tear Break-up Time | The tear break-up time with fluorescein solution is measured at the time of the exam in seconds. | at the time of the exam |
| Corneal Staining | Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining. | at the time of the exam |
| BG002 |
| Total |
Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
non diabetics over age 40
|
|
| Secondary | Tear Film Osmolarity | The tear film osmolarity is measured at the time of the exam. | Tear film osmolarity was measured in all patients, but two patients in the diabetic group had an insufficient tear film to obtain a reading. Therefore, only 36 diabetics were included. | Posted | Mean | Standard Error | mOsml/L | at the time of the exam | eyes | Participants |
|
|
|
| Other Pre-specified | OSDI Score | The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability. | All patients completed the OSDI survey | Posted | Mean | Standard Error | units on a scale | at the time of the exam |
|
|
|
| Other Pre-specified | Schirmer Score | The schirmer tear production test with anesthesia is completed at the time of the exam in mm of tear film absorption on the test strip after five minutes. Higher scores represent greater tear production. | Each patient underwent schirmer testing | Posted | Mean | Standard Error | mm | at the time of the exam | eyes | Participants |
|
|
|
| Other Pre-specified | Tear Break-up Time | The tear break-up time with fluorescein solution is measured at the time of the exam in seconds. | Each patient underwent tear break-up time testing | Posted | Mean | Standard Error | seconds | at the time of the exam | eyes | Participants |
|
|
|
| Other Pre-specified | Corneal Staining | Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining. | All patients underwent corneal staining evaluations using fluorescein. | Posted | Mean | Standard Error | units on a scale | at the time of the exam | eyes | Participants |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Non Diabetics | non diabetics over age 40 | 0 | 25 | 0 | 25 |
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |