Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07492966
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.
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).
Study:
NCT07492966
Study Brief:
Protocol Section:
NCT07492966