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Clinical study on prevention and treatment of pathological myopia and its associated complications using the method of integrative medicine

Clinical study on prevention and treatment of pathological myopia and its associated complications using the method of integrative medicine

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004301
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-01-21
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pathological myopia

Interventions

Sponsors

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Prevent and treat pathological myopia and its associated complications using the method of integrative medicine Inclusion criteria of pathological myopia (1)Signed informed consent; (2)At least one eye meets the criteria of diagnosis for pathological myopia:spherical equivalent <-6.00D,visual acuity or visual field abnormalities, and maculopathy of fundus including: macular atrophy, macular hemorrhage, peridisc atrophy and other fundus changes. 2. Prevent and control pathological myopia using the method of integrative medicine Inclusion criteria of potential pathological myopia with high risk: (1) Signed informed consent; (2) -6.00D < Spherical Equivalent after ciliary paralysis <= -1.00D for at least one eye; (3) <= 16 years oldmale or female; (4) Without pathological myopia-related maculopathy of fundus; (5) Without any other organic lesions affecting vision for both eyes; (6) With constitution of yang deficiency, qi deficiency, yin deficiency or other biased susceptible constitution for pathological myopia, or with parameters for high risk for pathological myopia..

Exclusion criteria

Exclusion criteria: 1. Prevent and treat pathological myopia and its associated complications using the method of integrative medicine Exclusion criteria of pathological myopia: (1)Exclude patients with systemic diseases caused other systemic impacts including eye impacts, such as hypertensive retinopathy, diabetic retinopathy and so on; (2)With moderate or severe liver dysfunction, or patients with severe cardiac, pulmonary or renal dysfunction, hematopoietic system diseases and mental illness; (3)Those who cannot cooperate with the investigation. 2. Prevent and control pathological myopia using the method of integrative medicine Exclusion criteria of potential pathological myopia with high risk: (1)Exclude patients with long-term application for therapy of traditional Chinese medicine (including traditional Chinese medicine, acupuncture, electroacupuncture, massage, moxibustion, pressing beans at auricular points and so on), or low concentration atropine eye drops, or visual training and other related treatment; (2)Exclude patients with serious systemic diseases, including cardio-cerebrovascular, liver, kidney, hematopoietic system and mental illness; (3)Exclude patients with mental diseases; (4)Exclude patients participating in other clinical trials; (5)Exclude patients with high risk for failure to accomplish the experiment or lead to complicate enrollment according to the judgment of the researchers.

Design outcomes

Primary

MeasureTime frame
Uncorrected eyesight;Regulatory function;Optical Coherence Tomography Angiography;Diopter;Axial length;

Secondary

MeasureTime frame
Intraocular pressure;Corrected eyesight;SLO;TCM Constitutions;Corneal curvature;TCM syndrome differentiation;Contrast sensitivity;Blood cell analysis;Fundus fluorescein angiography;Kidney function;Visual field;Liver function;Electrophysiology;Improvement of asthenopia and systemic symptoms;Opd;Routine urine examination;

Countries

China

Contacts

Public ContactBi Hongsheng

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

hongshengbi@163.com+86 13953113696

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026