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Protective effect of melatonin on optic nerve in glaucoma

Neuroprotective Efficacy and Safety of Exogenous Melatonin in Primary Open-Angle Glaucoma: A Single-Arm, Prospective Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101268
Enrollment
Unknown
Registered
2025-04-22
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Primary open-angle glaucoma 1. Early symptoms: insidious onset: no obvious symptoms in the early stage

Interventions

treatment group:Oral melatonin

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
36 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 36 years old, male or female, if both eyes meet the criteria, choose the eye with a better field of vision; 2. One of the following signs was found in the fundus examined by slit-lamp: the ratio difference between cups and plates of both eyes >= 0.2; The upper and lower edges of optic disc narrowed; Hemorrhage of optic disc; 3. The Angle of the room is open all around the room; 4. IOP > 21 mm Hg before treatment; 5. BCVA>=6/60; 6. The last five or more reliable visual field measurements have a time span of one year or more, and the progression rate of visual field MD under clinical target IOP is > -0.5 db/ year; 7. Thinning of the parapillary RNFL detected by optical coherence tomography; 8. Humphrey 30-2 Visual field Detection of typical glaucoma visual field changes (arc scotoma, paracentral visual field defect, nasal staircase, etc.); 9. Except for local IOP lowering drugs, no other health products or drugs with neurotrophic function have been taken orally within 1 month; 10.Voluntarily agreed to participate in the study, signed the informed consent, and had good treatment compliance;

Exclusion criteria

Exclusion criteria: 1. Congenital glaucoma; Juvenile glaucoma; Secondary open-angle glaucoma, such as post-traumatic, pseudoexfoliative or pigmentary glaucoma; Angle-closure glaucoma; 2. Previous history of ocular surface and intraocular surgery; Previous history of eye trauma; 3. Corneal, lens, retinochoroid or other optic nerve diseases (except pterygium, mild to moderate cataract); 4. bronchial asthma, or other reactive airway disease, severe heart failure, sinus bradycardia, hypotension, kidney disease, and diabetes; 5. Men who are known through medical history collection to be pregnant or lactating women, have a desire to have children and are unwilling to receive medical treatment that may affect fertility; 6. Participate in any other clinical trial within 3 months and administer the drug through the whole body or eye; 7. History of chemotherapy and malignant tumor; Autoimmune or immunosuppressive diseases; 8. History of drug and alcohol abuse; 9. Night watch required; Long-term oral melatonin; Patients with depression; Taking nifedipine or fluvoxamine, benzodiazepines or non-benzodiazepine hypnotics (zalyplon, Zolpidem and Zopiclone);

Design outcomes

Primary

MeasureTime frame
Visual field MD progression rate;

Secondary

MeasureTime frame
Sleep and mood evaluation;

Countries

China

Contacts

Public ContactHuang Jingjing

The Zhongshan Ophthalmic Center,Sun Yat-sen University

huangjingjing@gzzoc.com+86 20 66615460

Outcome results

None listed

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