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A randomized controlled trial of vitamin A softgels for open-angle glaucoma

A randomized controlled trial of vitamin A softgels for open-angle glaucoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058708
Enrollment
Unknown
Registered
2022-04-14
Start date
2022-04-26
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

glaucoma

Interventions

Intervention group A:Oral vitamin A 15,000 IU/day
Intervention group B:Oral vitamin A 10,000 IU/day
Intervention group C:Oral vitamin A 5,000 IU/day
Control group:Oral placebo

Sponsors

Beijing Tongren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 30-70. Sign the Informed Consent for this study voluntarily; 2. Clinical diagnosis of primary open angle glaucoma (high intraocular pressure POAG or NTG); 3. IOPmax of intraocular pressure lowering drugs/after antiglaucoma surgery/without drugs at 24H was lower than 21mmHg; 4. The diopter of at least one eye is less than - 10D, the MD value is higher than - 20dB, and the best corrected visual acuity is 20/40 or above.

Exclusion criteria

Exclusion criteria: 1. Unable or unwilling to sign the consent form, unwilling to accept random assignment, or unable to follow the research or follow-up procedures; 2. Other eye or neurological diseases that affect visual field; 3. Have a history of serious systemic diseases: hypertension (systolic blood pressure >= 180mmHg or diastolic blood pressure >= 100mmHg) and advanced heart disease, kidney disease, blood disease, tumor, COPD; 4. Patients with angle closure or secondary factors of glaucoma; 5. Pregnant women, pregnant women within one year and lactating women; 6. Patients with abnormal liver and kidney functions; 7. Patients with severe hypertriglyceridemia (>4.5 mmol/L or>400 mg/dL); 8. Aluminum hydroxide, sucralfate, oral contraceptives, other drugs mixed with or containing vitamin A or E, dicoumarin and its derivatives should be stopped during drug use, and those who cannot stop taking drugs should be excluded; 9. Patients who are participating in clinical trials of other drugs; 10. Have symptoms of vitamin A poisoning or the blood vitamin A level is higher than the upper limit of normal; 11. Patients who have undergone refractive surgery in the past and received other eye surgery or laser treatment within 6 months.

Design outcomes

Primary

MeasureTime frame
perimetry;

Secondary

MeasureTime frame
IOP;BCVA;Symptom Rating Scale;serum retinol;Blood Biochemistry;Routine blood tests;Dry eye related indicators;Contrast Sensitivity;OCT;Adverse drug reactions;Optic coherence tomography angiography(OCTA);Magnetic Resonance Imaging(MRI);

Countries

China

Contacts

Public ContactNingli Wang

Beijing Tongren Hospital

wningli@vip.163.com+86 135 1102 6669

Outcome results

None listed

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