An observational study in Congenital Cataract and Pediatric Cataract, sponsored by Jin Yang. Recruiting at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Jin Yang · Observational
This prospective multicenter observational study aims to evaluate the 5-year visual function and refractive outcomes in children undergoing surgery for congenital cataract. Key outcomes include best-corrected visual acuity, stereopsis, refractive error, and axial length growth. The study will help identify long-term trends and prognostic indicators after early cataract intervention in pediatric patients.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 400 is above the median of 156 across 39 observational studies indexed under Amblyopia.
Browse Amblyopia studies →Jin Yang is the lead sponsor of 7 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will enroll pediatric patients diagnosed with congenital cataract who underwent cataract extraction with or without intraocular lens (IOL) implantation. Participants must be able to complete regular postoperative follow-up assessments from the time of surgery up to 5 years. Both unilateral and bilateral cases are eligible. The study population is recruited from multiple tertiary eye centers in China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
congenital cataract
Visual Acuity
UDVA and BCVA will be assessed using age-appropriate optotypes (e.g., Snellen chart, ETDRS chart, or Lea symbols) and recorded in logMAR units at the last available follow-up, with a minimum duration of 5 years postoperatively.
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
axial length
AL
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Refractive Error
Refractive Error
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
IOP
intraocular pressure
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Corneal Curvature (K1 and K2) by Pentacam
Flat (K1) and steep (K2) corneal curvature values will be measured using Pentacam and recorded in diopters (D).
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Stereopsis
Stereopsis will be assessed using age-appropriate tools (e.g., Randot Preschool or Titmus Fly Test) and reported in seconds of arc. Loss of stereopsis is defined as \>3000 arcsec.
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
white to white
WTW (mm)
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
anterior chamber depth
ACD(mm)
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Complications
Any postoperative complications following congenital cataract surgery, including glaucoma, anterior capsular opacification (ACO), etc.
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Central Corneal Thickness (CCT)
Corneal pachymetry will be measured with Pentacam at the central point and reported in microns (µm).
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Corneal Astigmatism Magnitude
Corneal astigmatism will be calculated from the difference between steep and flat meridians (K2-K1) using Pentacam data, and reported in diopters.
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Binocular Fusion Assessment
Binocular fusion will be evaluated using the Worth 4-Dot test under near and distance conditions. Results will be categorized as "fusion", "suppression", or "alternation".
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2014 (actual). Primary completion is estimated for Dec 2030, 203 months after the start.
Of 16 observational studies under Amblyopia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 22. This study's planned 203 months is above that.
How these figures are worked out, and which studies are left out of them.
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Jin Yang