An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on … (NCT06614335) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
China300 participantsStarted 2024-03-26
Plain-language 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 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.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Orthostatic rate per operation
Timeframe: From enrollment to follow-up to 4 years of age
2
Stereoscopic establishment success rate
Timeframe: From enrollment to follow-up to 4 years of age