Ganyan -1 for the patients with dry eye
Objective: Ganyan-1 for the patients with dry eye Methods: The investigators enrolled 219 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, week2, week4, week8, week12, and week16.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
219
During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.
Participants received 0.1% sodium hyaluronate eye drop
During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 5 g per time for a duration of 4 weeks.
OSDI
The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/ areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eve (33-100).
Time frame: Baseline, week 2, 4, 8, 12 and 16
TBUT
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps' photos over time. A TBUT under 10 seconds is considered abnormal.
Time frame: Baseline, week 2, 4, 8, 12 and 16
Schirmer
The Schirmer test is objectively used to measure tear secretion without anesthetized. A healthy eye should wet more than 10 mm of the standard filter strip in 5 minutes. The travel rate along the test strip is proportional to the tear production rate.
Time frame: Baseline, week 2, 4, 8, 12 and 16
SF-36
36-Item Short Form Health Survey (SF36) measures quality of life on the basis of eight dimensions or concepts that are frequently used in health studies. These eight dimensions are estimated from eight subscales that examine physical functioning (SF36-PF), role functioning-physical (SF36-RP), bodily pain (SF36-BP), general health (SF36- GH), vitality (SF36-VT), social functioning (SF36-SF), role functioning-emotional (SF36-RE), mental health (SF36-MH) and reported health transition (SF36-HT). Item responses were ranaina from 0 (best) to 100 (worst), with hiaher scores are equivalent to areater severity of better quality of life.
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Participants will receive the following placebo Chinese herbal granules, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.
Time frame: Baseline, week 2, 4, 8, 12 and 16
SAS
The SAS is a 20-item self-report instrument designed to assess anxiety symptoms in clinical and research settings. This scale ranges from 20 to 80, with lower scores indicating better self-reported mental health and fewer anxiety symptoms.
Time frame: Baseline, week 2, 4, 8, 12 and 16
SDS
Medical Outcomes from study 20-Item Self-Rating Depression Scale. This scale range is 0-100 with lower scores indicating better self-reported mental health.
Time frame: Baseline, week 2, 4, 8, 12 and 16
OQAS II
Medical Outcomes from the OQAS II Visual Quality Assessment The OQAS II measures visual quality using several optical parameters. Scores are generated based on metrics like the Modulation Transfer Function (MTF) and Objective Scatter Index (OSI). The scale ranges from 0-100, with lower scores indicating better optical quality and fewer distortions. Change is calculated as the score at follow-up time points (e.g., post-treatment or surgery) minus the baseline score.
Time frame: Baseline, week 2, 4, 8, 12 and 16