The Cohort Study of Pediatric Cataract
Study Details
Study Description
Brief Summary
This retrospective-prospective bidirectional cohort study aims to observe ocular parameter changes, different surgical/vision recovery strategies and postoperative adverse effects among young children with cataract. The influence on psychology and cognitive function will be taken into consideration as well.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Pediatric cataract, one of the leading causes of childhood blindness globally, is complex and of great difficulty in treatment. Pediatric patients with cataract (congenital, traumatic or complicated) are enrolled. In this study, investigators will compare ocular parameter changes, different surgical/vision timing or recovery strategies and adverse effects among young children （age < 18 yo）before and after cataract surgery. The influence on psychology and cognitive function will be taken into consideration as well. The whole blood samples of participants and parents are collected and retained in our biobank for gene sequencing, hoping to explore the genetic factors in association with pathogenesis. For children received cataract surgery, samples of partial anterior capsular tissue and 1 ml aqueous humor were collected during operation for further analysis. Multimodal artificial intelligence analyses are performed to establish accurate diagnosis/treatment scheme and disease prediction model.
Study Design
Outcome Measures
Primary Outcome Measures
- Best-corrected visual acuity changes [Baseline and through study completion, an average of 1 year]
Best-corrected visual acuity changes are measured by visual acuity charts (Teller/Lea symbol/ETDRS chart) every 1 year at scheduled time
- Intraocular pressure changes [Baseline and through study completion, an average of 1 year]
Intraocular pressures are measured by NCT machine
- Refractive power changes [Baseline and through study completion, an average of 1 year]
Refractive power are measured at baseline and every visit at least every 1 year
- Ocular biological measurements changes [Baseline and through study completion, an average of 1 year]
Ocular biological measurements including axial length, corneal keratometry, anterior chamber angle/depth, corneal endothelial cell number and appearance
- Incidence changes of postoperative complications [Baseline and through study completion, an average of 1 year]
Incidence of postoperative complications, such as glaucoma-related adverse, myopic shift, strabismus and anisometropia and so on
Secondary Outcome Measures
- Other factors changes [Baseline and through study completion, an average of 1 year]
Sleep, depression, cognitive function are measured by questionnaires. Self-Rating Scale of Sleep: minimum value-1 point, maximum value-50, and higher scores mean worse outcome. Hamilton Depression Scale: <7 points-normal, and higher scores mean worse outcome. Loewenstein Cognitive Assessment: for every question, minimum 1 point, and maximum 4 points. Higher scores mean worse outcomes.
- BMI changes [Baseline and through study completion, an average of 1 year]
BMI is measured by technicians in every visit
- Blood pressure changes [Baseline and through study completion, an average of 1 year]
Diastolic and systolic blood pressure are measured by technicians in every visit
- Stereopsis changes [Baseline and through study completion, an average of 1 year]
Stereopsis is measured by Randot Stereotest
- Optical coherence tomography (OCT) changes [Baseline and through study completion, an average of 1 year]
Retinal thickness is measured and analyzed by OCT
Eligibility Criteria
Criteria
Inclusion Criteria:
- aged < 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent
Exclusion Criteria:
- adults
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Ophthalmic Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Zhongshan Ophthalmic Center, Sun Yat-sen University
Investigators
- Principal Investigator: Yizhi Liu, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
- Chak M, Wade A, Rahi JS; British Congenital Cataract Interest Group. Long-term visual acuity and its predictors after surgery for congenital cataract: findings of the British congenital cataract study. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4262-9.
- Long E, Zhang X, Liu Z, Wu X, Tan X, Lin D, Cao Q, Chen J, Lin Z, Wang D, Li X, Li J, Wang J, Li W, Lin H, Chen W, Liu Y. Dynamic response to initial stage blindness in visual system development. Clin Sci (Lond). 2017 Jun 28;131(13):1515-1527. doi: 10.1042/CS20170234. Print 2017 Jul 1.
- Solebo AL, Teoh L, Rahi J. Epidemiology of blindness in children. Arch Dis Child. 2017 Sep;102(9):853-857. doi: 10.1136/archdischild-2016-310532. Epub 2017 May 2. Review. Erratum in: Arch Dis Child. 2017 Oct;102(10):995.
- 2022KYPJ099