Evaluation of Eye Health Benefits of Black Tomato Extract

Not Applicable

Recruiting

• Conditions: High Myopia; Eye
• Interventions: Dietary Supplement: Placebo powder; Dietary Supplement: Black tomato extract powder

• Registration Number: NCT06412393
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

Verification of the efficacy of black tomato extract for eye health.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Study First Posted: 2024-05-14
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age greater than 20 and capable of providing informed consent.
• Daily usage of 3C (computer, communication, and consumer electronics) for more than 6 hours (OSDI screening - those experiencing dryness and fatigue in the eyes).
• BMI between 22 and 35.
• High myopia population (-5.00 to -9.00D)

Exclusion Criteria

• History of any eye surgery (e.g., strabismus surgery, refractive surgery).
• Presence of systemic diseases affecting the anterior surface of the eye.
• Long-term use of medications affecting the anterior surface of the eye.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo powder	Placebo powder	Dietary Supplement: Placebo powder
Black tomato extract powder	Black tomato extract powder	Dietary Supplement: Black tomato extract powder

Primary Outcome Measures

Name	Time	Method
Grading of Retinal Vascular Diameter	Change from Baseline at 8 weeks	Measurement of Grading of Retinal Vascular Diameter using a fundus camera.
Positive Relative Accommodation (PRA)	Change from Baseline at 8 weeks	Measurement of Positive Relative Accommodation using a phoropter.
Accommodative Facility	Change from Baseline at 8 weeks	Measurement of Accommodative Facility using a Flipper lens ±2.00D.
Positive Fusional Vergence (PFV)	Change from Baseline at 8 weeks	Measurement of Positive Fusional Vergence using a phoropter.
Intraocular Pressure Measurement (IOP)	Change from Baseline at 8 weeks	Measurement of Intraocular Pressure using a non-contact tonometer. Unit: mmHg
Visual Contrast Sensitivity Function	Change from Baseline at 8 weeks	Perform the Visual Contrast Sensitivity Test (Distance and near) under environmental illumination/dark/bright conditions.
Negative Fusional Vergence (NFV)	Change from Baseline at 8 weeks	Measurement of Negative Fusional Vergence using a phoropter.
Negative Relative Accommodation (NRA)	Change from Baseline at 8 weeks	Measurement of Negative Relative Accommodation using a phoropter.

Secondary Outcome Measures

Name	Time	Method
Best-corrected visual acuity	Change from Baseline at 8 weeks	Measurement of Best-corrected visual acuity (distance and near) using a logMAR chart.
The change of Endothelin-1 (ET-1)	Change from Baseline at 8 weeks	Fasting venous blood will be sampled to measure concentrations of ET-1.
The change of Tumor necrosis factor-α (TNF-α)	Change from Baseline at 8 weeks	Fasting venous blood will be sampled to measure concentrations of TNF-α.
Questionnaire Survey - Ocular Surface Disease Index (OSDI)	Change from Baseline at 8 weeks	The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan