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Ngf-chitosan for the treatment of optic nerve injury

A Study on the Safety and Efficacy of NGF-Chitosan in the Treatment of Patients with Traumatic Optic Neuropathy (with Optic Canal Fracture)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112047
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Optic nerve injury that have suffered traumatic optic canal fractures in one eye and have no light perception

Interventions

Experimental group:Ngf-chitosan gel implantation

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years; injury occurred within 72 hours to 2 weeks; diagnosed with traumatic optic neuropathy (TON) in a single eye. 2. Diagnostic criteria: According to the "Expert Consensus on Endoscopic Transnasal Optic Canal Decompression for Traumatic Optic Neuropathy in China (2016)", the TON diagnostic criteria are as follows: Necessary conditions: (1) History of cranial, orbital, or maxillofacial trauma, especially to the frontal or temporal region; (2) Acute post-injury visual impairment such as decreased vision or blindness, visual field defects, or color vision disorder, excluding preexisting diseases. Supportive conditions: (1) Positive RAPD without intraocular abnormalities causing the positive RAPD; (2) F-VEP examination shows disappearance of the visual waveform or prolonged P100 latency and reduced amplitude, with no severe retinal lesions observed. When only one eye is affected or when both eyes are affected to different degrees, supportive condition (1) should be met; when both eyes are affected similarly, supportive condition (2) should be met. If both necessary conditions are present along with the relevant supportive condition, TON can be diagnosed. 3. The affected eye has no light perception, and there is no sign of improvement during preoperative conservative treatment. 4. The patient is conscious, communicates smoothly, voluntarily participates in this study, and has personally signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Combined with retinal and optic nerve avulsion injuries; 2.Patients with previous craniocerebral surgery or craniocerebral injury; Preoperative CTA vascular scan revealed definite or suspicious abnormalities of the internal carotid artery or ophthalmic artery. 3.There are contraindications for surgery, and the preoperative indication indicates chronic infection of the paranasal sinuses. 4.Suffering from other eye diseases (including vitreous hemorrhage, glaucoma, high myopia); 5.Lack of informed consent capacity or restricted informed consent; Lack of capacity for civil conduct or limited capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
Routine ophthalmic examination findings;Vital signs;Ophthalmic imaging and electrophysiological examination indicators;Laboratory examination indicators;

Secondary

MeasureTime frame
Cranial imaging examination indicators;

Countries

China

Contacts

Public ContactLiang Chen

Huashan Hospital, Fudan University

chenlianghs@126.com+86 21 6564 2662

Outcome results

None listed

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