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

Phase 1

Recruiting

• Conditions: Pathological myopia

• Registration Number: ITMCTR2100004301
• Lead Sponsor: Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ncorrected eyesight;Regulatory function;Optical Coherence Tomography Angiography;Diopter;Axial length;

Secondary Outcome Measures

Name	Time	Method
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;