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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| congenital cataract | congenital cataract |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. |
| axial length | AL | 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 | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| IOP | intraocular pressure | 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). |
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Inclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuanqiao Lin | Contact | +8615088920668 | 1532483480@qq.com | |
| Lei Cai | Contact | 1532483480@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Yang | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye and ENT hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| 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. | 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) | 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) | 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. | 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). | 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. | 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". | Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively. |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |