Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:52 PM
Study NCT ID:
NCT07492966
Status:
COMPLETED
Last Update Posted:
2026-03-25
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exosomes Effect on Visual Function in CVI
Sponsor:
Hatice Semrin Timlioglu İper
Organization:
Study Overview
Official Title:
The Effect of Nasal Mesenchymal Exosome Administration on Vision Function in CVI
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about the effects of nazally applied exosome treatment on visual functions in children with Phase 1 Cerebral visual impairment (CVİ).
The main question it aims to answer is:
Does exosome therapy administered via the nasal route for neurological disorders in children with Phase 1 CVI also show a beneficial effect on visual functions? Researchers will compare visual and visual function findings before and after the exosome application to determine whether the exosome application is also effective in visual function.
Participants:
* They will receive exosomes via the nasal route every month for 6 months.
* They will visit the clinic every month for monitoring and tests.
The main question it aims to answer is:
Does exosome therapy administered via the nasal route for neurological disorders in children with Phase 1 CVI also show a beneficial effect on visual functions? Researchers will compare visual and visual function findings before and after the exosome application to determine whether the exosome application is also effective in visual function.
Participants:
* They will receive exosomes via the nasal route every month for 6 months.
* They will visit the clinic every month for monitoring and tests.
Detailed Description:
Purpose Cortical visual impairment (CVI) denotes a pediatric visual deficit arising from non-ocular etiologies, purportedly linked to perturbations in visual cortical processing regions. This syndrome characteristically ensues from perinatal insults-such as asphyxia, prematurity, neonatal hypoglycemia, or hypoxia-inflicting damage upon retro-geniculate visual pathways and cortical centers. Empirical evidence underscores cerebral neuroplasticity, facilitating reorganization despite congenital retro-geniculate lesions; nonetheless, CVI manifests heterogeneous visual and cognitive sequelae. With 17% of neonates necessitating intensive care, advancements in neonatal care have augmented survival, concomitantly escalating the prevalence of neurodevelopmental disorders including CVI and cerebral palsy (CP), thereby spurring investigational reparative modalities such as stem cell and molecular therapeutics.
Methods This investigation prospectively enrolled 32 children aged 0.6-13 years diagnosed with CVI, who received intranasal exosome therapy (5 × 10\^6 particles/dose) between 2023 and 2024. Administration occurred in 4-6 iterations at monthly intervals. Comprehensive neuro-ophthalmic evaluations encompassed dynamic retinoscopy, preferential looking assessments (LEA and Cardiff cards) for visual acuity and Visual Function Index, alongside surveillance of ventral stream deficits (e.g., delayed gaze, complexity aversion) and dorsal stream impairments (e.g., visuomotor orienting). Statistical analyses employed IBM SPSS Statistics version 25.0 (IBM Corp., Armonk, NY, USA).
Methods This investigation prospectively enrolled 32 children aged 0.6-13 years diagnosed with CVI, who received intranasal exosome therapy (5 × 10\^6 particles/dose) between 2023 and 2024. Administration occurred in 4-6 iterations at monthly intervals. Comprehensive neuro-ophthalmic evaluations encompassed dynamic retinoscopy, preferential looking assessments (LEA and Cardiff cards) for visual acuity and Visual Function Index, alongside surveillance of ventral stream deficits (e.g., delayed gaze, complexity aversion) and dorsal stream impairments (e.g., visuomotor orienting). Statistical analyses employed IBM SPSS Statistics version 25.0 (IBM Corp., Armonk, NY, USA).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: