The Neuroprotective Effect of PEG-GCSF in the Traumatic Optic Neuropathy
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
The clinical trial will be a phase 1, semi-experimental trial, which will be performed in
Hualien Tzu Chi Hospital. Twenty patients will be recruited in this study starting from the
2nd year of the project to the 3rd year of the project and will go through comprehensive eye
and systemic examination in the Hualien Tzu Chi Hospital. Indirect TON (ITON) patients are
defined as reduced best corrected visual acuity (BCVA), visual field, color vision, and
positive relatively afferent pupillary defect (RAPD) with normal fundus and optic nerve
examination and no evidence of direct trauma to optic nerve on spiral orbital and optic canal
computer tomography (CT) scan. Therefore, all patients will have examinations of BCVA, visual
field, color vision, RAPD, FVEP, CT scan, and IOP for defining ITON patients one day before
Neulasta injection. Patient also underwent renal function test, liver function test,
coagulation test, and complete blood count before the treatment. Patients who meet the
enrollment criteria (inclusion and exclusion) will be fully informed of this treatment and
then an informed consent will be obtained. After patient enrolment, the patient will be
intravitreally administrated by 0.15 mL of Neulasta in the injured eye. Firstly, the injured
eye will be treated with iodine solution for disinfection and then will be treated with
Alcaine eye drop for topic anesthesia. The 0.15 mL of Neulasta will be filled into 1 mL of
syringe equipped with 30 gauge beveled needle for intravitreal injection. During injection of
Neulasta solution, the anterior chamber decompression will be performed for IOP balance. The
aqueous humor from anterior chamber will be collected for further microarray analysis. After
Neulasta treatment, Tobradex eyedrops (Alcon) will be given on the injected eye, four times a
day. Patient will be hospitalized for one day to monitor BCVA, IOP, fundus condition,
complete blood count, and any adverse event. During 3-month follow-up trial, each patient
will be regularly monitored 7 days and 1, 3 months after treatments by determining the BCVA,
the RPAD, the color vision, visual field, the latency of P-100 wave in FVEP, and the RNFL
thickness, IOP, and complete blood count.