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Safety and Efficacy Study of Local Application of bFGF in the treatment of Traumatic Optic Neuropathy

Safety and Efficacy Preliminary Study of Local Application of bFGF in the treatment of Traumatic Optic Neuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117059
Enrollment
Unknown
Registered
2026-01-19
Start date
2024-06-19
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Traumatic optic neuropathy

Interventions

Experimental group:Perform routine optic canal decompression surgery and implant bFGF bio-release material at the lesion site
Control Group:Perform routine optic canal decompression surgery and transplant biodegradable gelatin blank materials at the lesion site

Sponsors

Wenzhou Medical University Affiliated Ophthalmology Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as TON (either single eye or both eyes can be included); 2. Within 3 months after injury; 3. Age ranging from 8 years to 65 years; 4. Corrected visual acuity ranging from light perception to 0.1; 5. Within 2 weeks after injury, no improvement in vision was observed after 3 days of hormone shock treatment (methylprednisolone 1000 mg/day); 6. The patient was conscious, expressed fluently, voluntarily participated in this study, and personally signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with retinal and optic nerve avulsion injuries; 2. Preoperative CTA vascular scan revealed definite or suspected abnormalities of the internal carotid artery or ophthalmic artery; 3. There are surgical contraindications, and preoperative examination indicated chronic infection in the paranasal sinuses; 4. Suffer from other ocular diseases (including vitreous hemorrhage, glaucoma, high myopia); 5. Lens opacity; 6. History of diabetes; 7. Lack of capacity for informed consent or restricted informed consent; 8. Lack of civil capacity or restricted civil capacity.

Design outcomes

Primary

MeasureTime frame
Best spectacle-corrected visual acuity;

Secondary

MeasureTime frame
Flash visual evoked potential;Peripapillary vessel density;Peripapillary RNFL thickness;Temperature;Pattern visual evoked potential;Graphic electroretinogram;Pupillary light response;Optic nerve head optical coherence tomography circle scans;Cranial computed tomography ;Slit lamp examination;Fundus photography;Visual field measurement;Respiration rate;Blood pressure;Heart rate;Mental state;Consciousness assessment;

Countries

China

Contacts

Public ContactWu Wencan

Wenzhou Medical University Affiliated Ophthalmology Hospital

wuwencan118@163.com+86 577 8806 8888

Outcome results

None listed

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