Congenital EsotropiastrabismusNCT06614335
An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
An observational study of Congenital Esotropia, run by Qiyu Bo at 1 site in China.
Trial summary
Through high-throughput sequencing and genotype/clinical phenotype/image 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… Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Congenital Esotropia
- What is being tested?
- After 6 months of observation, there was still a residual inclination of more than 15 prism degrees which needed to be corrected by a second operation
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 30 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 0-3 years of age undergoing surgery for congenital esotropia.
Who may be able to join
- Children diagnosed with congenital esotropia and treated with surgery, regardless of gender;
- Children aged 0-36 months;
- The guardian of the patient voluntarily signs the informed consent.
Who cannot join
- Esotropia found within 6 months of age due to anatomical abnormalities, extraocular muscle fibrosis, or paralysis or absence of nerves innervating the extraocular muscle;
- There are diseases or structural abnormalities affecting ocular vision development, such as congenital cataract, congenital microeyeball, congenital glaucoma, genetic or blinding eye diseases with clear genetic mutations, such as Lerber amaurosis and ocular albinism;
- Those deemed unsuitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Through high-throughput sequencing and genotype/clinical phenotype/image 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.
Read the 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 0.25%-0.50%. 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 child\'s 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 child\'s 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.
- Conditions
- Congenital Esotropia
- Being tested
- After 6 months of observation, there was still a residual inclination of more than 15 prism degrees which needed to be corrected by a second operation
- Keywords
- Congenital Esotropia, Infantile Esotropia, IE, Surgical alignment rate, Stereoscopic establishment success rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After 6 months of observation, there was still a residual inclination of more than 15 prism degrees which needed to be corrected by a second operationOther
All IE patients enrolled were patients who had undergone corrective surgery for strabismus. Postoperative strabismus with 10 prism degrees of overcorrection or undercorrection is within the normal range. During postoperative follow-up, patients with more than 10 prism degrees of residual esotropia were treated conservally with foot orthoscopy according to their refractive status. After 6 months of observation, there were still more than 15 prism degrees of residual esotropia that needed to be corrected by a second operation. For extropia with overcorrection greater than 10 prism degrees, cross-eye training, negative mirror + prism stimulation and conservative observation and fusion training are given in the early stage, and can not be improved within 6 months, requiring a second surgical correction.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective analysis group | A retrospective analysis was performed on 220 patients who underwent IE surgery, followed up to 4 years of age, and the risk factors affecting the success rate of stereoscopic establishment were analyzed, such as strabismus, age of surgery, MRI brain features, concomitant symptoms of strabismus, etiology, refractive status, etc. The optimal timing of IE surgery and the imaging evidence related to the selection of the optimal timing were determined according to the operative orthostatic rate and the success rate of stereoscopic establishment, and the prediction model of the success rate of binocular stereoscopic establishment after surgery at different time points was constructed. Receives: Other: After 6 months of observation, there was still a residual inclination of more than 15 prism degrees which needed to be corrected by a second operation | |
| External validation cohort of patients undergoing surgery | An externally validated retrospective analysis of 60-80 patients undergoing IE surgery was conducted to construct a prediction model for the success rate of binocular stereovision establishment after surgery at different time points. Receives: Other: After 6 months of observation, there was still a residual inclination of more than 15 prism degrees which needed to be corrected by a second operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic rate per operation
Surgical alignment: Clinically, the standard of surgical alignment is that the postoperative eye position is less than plus or minus 10 prism degrees. Measurements are made through a prism.
Measured: From enrollment to follow-up to 4 years of age
Stereoscopic establishment success rate
The success of stereoscopic establishment is qualitative index: yes or no. If so, further examination of fine stereoscopic acuity is performed. Titmus stereoscopic examination method was used for the examination: the examination images were composed of 3 groups: (1) Qualitative screening images of flies, which were used to quickly screen whether the subjects had stereoscopic sensation, and it was normal to perceive the float of fly wings; (2) Animal quantitative map, each row consists of 5 animal pictures, a total of 3 groups, the design parallax values are 400 \", 200 \"and 100\", mainly used for children under 4 years old; (3) Circle quantitative pictures, a total of 9 groups, from 800 \"~ 40\" divided into 9 levels of parallax. Because the above pictures are vivid, easy to use, extensive, especially suitable for children\'s group inspection.
Measured: From enrollment to follow-up to 4 years of age
Secondary outcomes (1)
Secondary operation rate
Measured: From enrollment to follow-up to 4 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start26 Mar 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital EsotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiyu Bo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiyu Bo, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614335
- Sponsor's protocol ID
- CCTR-2023A02
- Acronym
- strabismus
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
- ClinicalTrials.gov ID
- NCT06614335
- Acronym / sponsor ID
- strabismus / CCTR-2023A02
- Conditions
- Congenital Esotropia
- Keywords
- Congenital Esotropia, Infantile Esotropia, IE, Surgical alignment rate, Stereoscopic establishment success rate
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qiyu BoUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through high-throughput sequencing and genotype/clinical phenotype/image 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 0.25%-0.50%. 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 child\'s 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 child\'s 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective analysis group | – | Other: After 6 months of observation, there was still a residual inclination of more than 15 prism degrees which needed to be corrected by a second operationA retrospective analysis was performed on 220 patients who underwent IE surgery, followed up to 4 years of age, and the risk factors affecting the success rate of stereoscopic establishment were analyzed, such as strabismus, age of surgery, MRI brain features, concomitant symptoms of strabismus, etiology, refractive status, etc. The optimal timing of IE surgery and the imaging evidence related to the selection of the optimal timing were determined according to the operative orthostatic rate and the success rate of stereoscopic establishment, and the prediction model of the success rate of binocular stereoscopic establishment after surgery at different time points was constructed. |
| External validation cohort of patients undergoing surgery | – | Other: After 6 months of observation, there was still a residual inclination of more than 15 prism degrees which needed to be corrected by a second operationAn externally validated retrospective analysis of 60-80 patients undergoing IE surgery was conducted to construct a prediction model for the success rate of binocular stereovision establishment after surgery at different time points. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 0-3 years of age undergoing surgery for congenital esotropia.
Key inclusion criteria (3 listed)
- Children diagnosed with congenital esotropia and treated with surgery, regardless of gender;
- Children aged 0-36 months;
- The guardian of the patient voluntarily signs the informed consent.
Key exclusion criteria (3 listed)
- Esotropia found within 6 months of age due to anatomical abnormalities, extraocular muscle fibrosis, or paralysis or absence of nerves innervating the extraocular muscle;
- There are diseases or structural abnormalities affecting ocular vision development, such as congenital cataract, congenital microeyeball, congenital glaucoma, genetic or blinding eye diseases with clear genetic mutations, such as Lerber amaurosis and ocular albinism;
- Those deemed unsuitable for inclusion by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| After 6 months of observation, there was still a residual inclination of more than 15 prism degrees which needed to be corrected by a second operationAll IE patients enrolled were patients who had undergone corrective surgery for strabismus. Postoperative strabismus with 10 prism degrees of overcorrection or undercorrection is within the normal range. During postoperative follow-up, patients with more than 10 prism degrees of residual esotropia were treated conservally with foot orthoscopy according to their refractive status. After 6 months of observation, there were still more than 15 prism degrees of residual esotropia that needed to be corrected by a second operation. For extropia with overcorrection greater than 10 prism degrees, cross-eye training, negative mirror + prism stimulation and conservative observation and fusion training are given in the early stage, and can not be improved within 6 months, requiring a second surgical correction. | Other | External validation cohort of patients undergoing surgery, Retrospective analysis group |
Primary outcome
Orthostatic rate per operation
Time frame: From enrollment to follow-up to 4 years of age
Surgical alignment: Clinically, the standard of surgical alignment is that the postoperative eye position is less than plus or minus 10 prism degrees. Measurements are made through a prism.
Stereoscopic establishment success rate
Time frame: From enrollment to follow-up to 4 years of age
The success of stereoscopic establishment is qualitative index: yes or no. If so, further examination of fine stereoscopic acuity is performed. Titmus stereoscopic examination method was used for the examination: the examination images were composed of 3 groups: (1) Qualitative screening images of flies, which were used to quickly screen whether the subjects had stereoscopic sensation, and it was normal to perceive the float of fly wings; (2) Animal quantitative map, each row consists of 5 animal pictures, a total of 3 groups, the design parallax values are 400 \", 200 \"and 100\", mainly used for children under 4 years old; (3) Circle quantitative pictures, a total of 9 groups, from 800 \"~ 40\" divided into 9 levels of parallax. Because the above pictures are vivid, easy to use, extensive, especially suitable for children\'s group inspection.
1 secondary outcome
Secondary operation rate
Time frame: From enrollment to follow-up to 4 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Esotropia
RecruitingObservational study
Genetic Studies of Strabismus, Nystagmus, and Associated Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Esotropia, run by Qiyu Bo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthostatic rate per operation (time frame: From enrollment to follow-up to 4 years of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.