Congenital Cataract, Pediatric Cataract
Conditions
Keywords
Congenital Cataract, Pediatric Cataract Surgery, Visual Function, Stereopsis, Amblyopia, Long-term Outcomes
Brief summary
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.
Interventions
None listed
Sponsors
Jin Yang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of congenital cataract * Underwent cataract extraction before 1 year of age * Available for regular follow-up for at least 5 years postoperatively * Written informed consent from legal guardian
Exclusion criteria
* Acquired cataract or traumatic origin * Associated ocular malformations (e.g., microphthalmia, coloboma) * Systemic syndromes affecting vision (e.g., Down syndrome) * History of secondary surgery affecting visual outcome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | 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. |
| axial length | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | AL |
| Refractive Error | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | Refractive Error |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| white to white | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | WTW (mm) |
| anterior chamber depth | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | ACD(mm) |
| Complications | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | Any postoperative complications following congenital cataract surgery, including glaucoma, anterior capsular opacification (ACO), etc. |
| IOP | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | intraocular pressure |
| Corneal Astigmatism Magnitude | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | Corneal astigmatism will be calculated from the difference between steep and flat meridians (K2-K1) using Pentacam data, and reported in diopters. |
| Binocular Fusion Assessment | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | 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. |
| Central Corneal Thickness (CCT) | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | Corneal pachymetry will be measured with Pentacam at the central point and reported in microns (µm). |
| Corneal Curvature (K1 and K2) by Pentacam | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | Flat (K1) and steep (K2) corneal curvature values will be measured using Pentacam and recorded in diopters (D). |
| Stereopsis | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. | 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. |
Countries
China
Contacts
Primary ContactXuanqiao Lin
Backup ContactLei Cai
Outcome results
None listed