Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorJin Yang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: congenital cataract
Trial outcomes
Primary outcomes
1
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.2
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.3
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jin Yang
Lead sponsor
Eye & ENT Hospital of Fudan University
Sponsor institution
Source ClinicalTrials.gov