Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
strabismus
Brief Summary:
Through high-throughput sequencing and genotypeclinical phenotypeimage phenotype analysis this study will detect and find the clinical characteristics genetic mode and gene diagnosis of children with congenital strabismus and their families and explore the causes and pathogenesis of their diseases so as to provide individualized treatment basis for the establishment of postoperative binocular vision in children undergoing congenital strabismus surgery At the same time it provides reference for the brain and intelligence development of children in the process of growth
Detailed Description:
Congenital esotropia also known as infantile esotropia IE is a condition in which the eyes deviate inward at birth or within the first six months of life with an incidence of 025-050 Its clinical features include a large angle of deviation with alternating gaze the absence of binocular vision and often accompanied by latent nystagmus vertical disparity deviation etc Due to its early onset and constant nature the damage to binocular vision function is more severe than that of other types of strabismus and usually requires surgical correction of the eye position to improve the child39s binocular vision function However the timing of IE surgical intervention has always been a topic of concern and controversy among doctors some scholars believe that surgery should be performed in the early stage within 4-6 months after birth or the early stage 2 years before as early surgery is beneficial to the recovery and establishment of binocular vision function in children others argue that surgery should be performed in the late stage 2 years after birth as if the child is too young the preoperative examination results may not be accurate the amount of surgery is difficult to determine and the incidence of overcorrection and undercorrection is higher and the improvement in visual function after surgery is not significant Therefore it can be seen that the earlier the surgery is performed the higher the risk of secondary surgery if it is too late there is a risk of missing the opportunity to establish good stereoscopic vision Therefore finding the optimal surgical timing between 3 and 24 months after birth based on the surgical alignment rate and the success rate of stereoscopic vision establishment is an important clinical issue
In recent years Professor Ing M R has reported 16 cases of patients who underwent correction surgery within 6 months of birth finding that visual quality of patients who underwent eye position correction surgery between 4-5 months after birth was not better than that of patients who underwent surgery at 6 months or older suggesting that not all patients have the potential to establish normal binocular vision The study reported that the occurrence of exaggerated inferior oblique muscle activity and separation of vertical deviation DVD after surgery can affect the recovery and establishment of binocular vision suggesting that dysfunction of visual cortex motor processing can also affect binocular vision Furthermore some children with congenital esotropia were found to have hidden white matter softening lesions suggesting that IE patients have hidden damage to brain structure Therefore various causes of brain structure abnormalities are important factors affecting the establishment of stereoscopic vision and it is very necessary to use safe non-invasive imaging technology and genetic testing technology to further understand the characteristics of brain structure and function before and after surgery in IE patients the timing of surgery and the relationship with the establishment of binocular vision
In recent years increasing evidence has shown that the onset of congenital esotropia etiology is related to primary disorders of the visual cortex and motor processing centers in the brain of the patient Some children with congenital esotropia were found to have hidden white matter softening lesions cerebellar hypoplasia or obvious decoupling trends in functional connectivity networks in brain regions suggesting that abnormalities in brain structure and function etiology are closely related to eye position More importantly the preliminary functional MRI analysis conducted by the research team found that the longer the duration of congenital esotropia the greater the negative impact on the child39s brain structure and function network connection After the strabismus in congenital esotropia patients was corrected by surgery there was a widespread improvement in the functional network connection of the brain suggesting that changes in visual experience can cause changes in human brain function and structure Therefore by analyzing the characteristics of brain structure and function before and after surgery in patients it is possible to provide imaging evidence for the choice
In recent years Professor Ing M R has reported 16 cases of patients who underwent correction surgery within 6 months of birth finding that visual quality of patients who underwent eye position correction surgery between 4-5 months after birth was not better than that of patients who underwent surgery at 6 months or older suggesting that not all patients have the potential to establish normal binocular vision The study reported that the occurrence of exaggerated inferior oblique muscle activity and separation of vertical deviation DVD after surgery can affect the recovery and establishment of binocular vision suggesting that dysfunction of visual cortex motor processing can also affect binocular vision Furthermore some children with congenital esotropia were found to have hidden white matter softening lesions suggesting that IE patients have hidden damage to brain structure Therefore various causes of brain structure abnormalities are important factors affecting the establishment of stereoscopic vision and it is very necessary to use safe non-invasive imaging technology and genetic testing technology to further understand the characteristics of brain structure and function before and after surgery in IE patients the timing of surgery and the relationship with the establishment of binocular vision
In recent years increasing evidence has shown that the onset of congenital esotropia etiology is related to primary disorders of the visual cortex and motor processing centers in the brain of the patient Some children with congenital esotropia were found to have hidden white matter softening lesions cerebellar hypoplasia or obvious decoupling trends in functional connectivity networks in brain regions suggesting that abnormalities in brain structure and function etiology are closely related to eye position More importantly the preliminary functional MRI analysis conducted by the research team found that the longer the duration of congenital esotropia the greater the negative impact on the child39s brain structure and function network connection After the strabismus in congenital esotropia patients was corrected by surgery there was a widespread improvement in the functional network connection of the brain suggesting that changes in visual experience can cause changes in human brain function and structure Therefore by analyzing the characteristics of brain structure and function before and after surgery in patients it is possible to provide imaging evidence for the choice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None