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A randomized trial on integration of traditional and western medicine treatment to reduce the incidence of postoperative transient intraocular pressure elevation

A randomized trial on integration of traditional and western medicine treatment to reduce the incidence of postoperative transient intraocular pressure elevation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082011
Enrollment
Unknown
Registered
2024-03-19
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

primary open-angle glaucoma

Interventions

Experimental group:PCP surgery + traditional Chinese medicine Astragalus 30g,angelica 6g,red peony 10g,earthworm 12g,chuanxiong 10g,safflower10g,peach kernel 10g,butterflybush flower 10g The medicati
Control group : PCP surgery + placebo

Sponsors

Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Patients with a diagnosis of primary open-angle glaucoma or juvenile open-angle glaucoma; Primary angle-closure glaucoma diagnostic criteria: Manifested as pathological elevated intraocular pressure [generally considered when the peak intraocular pressure exceeds 21 mmHg over 24 hours (1 mmHg = 0.133 kPa)], accompanied by glaucomatous optic nerve damage (changes in optic disc and RNFL morphology) and/or glaucomatous visual field defects. Patients should demonstrate open angles on gonioscopy, and other factors potentially causing elevated intraocular pressure must be excluded. Juvenile open-angle glaucoma diagnostic criteria: Similar to primary open-angle glaucoma, onset age between 3 and 35 years, with essentially normal angle structures, absence of other congenital anomalies or syndromes, and no ocular enlargement (2) Age between 18 and 55 years old; (3) Glaucoma patients scheduled for PCP; (4) Willing to undergo traditional Chinese medicine treatment postoperatively; (5) Signed informed consent and voluntarily participating in this study. Note: Patients who simultaneously meet all five criteria mentioned above can be included in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary glaucoma or glaucoma following other surgeries; 2. Patients self-administering neuroprotective drugs or traditional Chinese medicine for conditions other than using intraocular pressure-lowering medications or medications for underlying diseases (including hypertension, diabetes, etc.); 3. Poorly controlled diabetic patients or those with diabetic retinopathy; 4. Patients planning for pregnancy, pregnant, or breastfeeding; 5. Patients with a tendency for bleeding (e.g., long-term use of aspirin or anticoagulants such as warfarin, abnormal coagulation function test results exceeding normal values by two times or more); 6. Patients unable to adhere to scheduled follow-ups or unwilling to sign informed consent. Note: Patients who meet any of the criteria mentioned above should be excluded from the study.

Design outcomes

Primary

MeasureTime frame
The incidence of transient intraocular pressure elevation after surgery;

Secondary

MeasureTime frame
Postoperative follow-up of intraocular pressure;Transient peak intraocular pressure;Duration of transient intraocular pressure elevation;

Countries

China

Contacts

Public ContactYuanbo Liang

Eye Hospital of Wenzhou Medical University

yuanboliang@126.com+86 182 5774 8686

Outcome results

None listed

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