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Verification of the efficacy of black tomato extract for eye health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo powder | Placebo Comparator | Dietary Supplement: Placebo powder |
|
| Black tomato extract powder | Experimental | Dietary Supplement: Black tomato extract powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black tomato extract powder | Dietary Supplement | take 2 packets per day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure Measurement (IOP) | Measurement of Intraocular Pressure using a non-contact tonometer. Unit: mmHg | Change from Baseline at 8 weeks |
| Grading of Retinal Vascular Diameter | Measurement of Grading of Retinal Vascular Diameter using a fundus camera. | Change from Baseline at 8 weeks |
| Visual Contrast Sensitivity Function | Perform the Visual Contrast Sensitivity Test (Distance and near) under environmental illumination/dark/bright conditions. | Change from Baseline at 8 weeks |
| Negative Fusional Vergence (NFV) | Measurement of Negative Fusional Vergence using a phoropter. | Change from Baseline at 8 weeks |
| Positive Fusional Vergence (PFV) | Measurement of Positive Fusional Vergence using a phoropter. | Change from Baseline at 8 weeks |
| Negative Relative Accommodation (NRA) | Measurement of Negative Relative Accommodation using a phoropter. | Change from Baseline at 8 weeks |
| Positive Relative Accommodation (PRA) | Measurement of Positive Relative Accommodation using a phoropter. | Change from Baseline at 8 weeks |
| Accommodative Facility |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire Survey - Ocular Surface Disease Index (OSDI) | The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. | Change from Baseline at 8 weeks |
| The change of Endothelin-1 (ET-1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo-Yie Chen boychen@csmu.edu.tw | Chung Shan Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University | Taichung | 402 | Taiwan |
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| Placebo powder | Dietary Supplement | take 2 packets per day for 8 weeks |
|
Measurement of Accommodative Facility using a Flipper lens ±2.00D. |
| Change from Baseline at 8 weeks |
Fasting venous blood will be sampled to measure concentrations of ET-1.
| Change from Baseline at 8 weeks |
| The change of Tumor necrosis factor-α (TNF-α) | Fasting venous blood will be sampled to measure concentrations of TNF-α. | Change from Baseline at 8 weeks |
| Best-corrected visual acuity | Measurement of Best-corrected visual acuity (distance and near) using a logMAR chart. | Change from Baseline at 8 weeks |