About this trial
Selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. This prospective, randomized controlled study aims to compare the prognosis of posterior continuous curvilinear capsulorhexis (PCCC) with or without anterior vitrectomy (A-Vit) in treating congenital cataracts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children with bilateral congenital cataracts without other ocular abnormalities
Gestational age at birth >37 weeks
No more than 18 years old
Pupils could dilate normally pre-operation
Disqualifiers
Intraocular pressure >21 mmHg
History of ocular trauma and intraocular surgery
Trial design
Parallel
Treatments tested in this trial
PCCC procedure without A-vit
Procedure/SurgeryIn this randomized clinical trial, patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo PCCC+A-Vit procedure, while the fellow eye is undergoing PCCC procedure without A-Vit.
PCCC+A-Vit procedure
Procedure/SurgeryPCCC+A-Vit procedure
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with visual axis opacification
Number of participants with visual axis opacification evaluated based on the retro-illumination.
Number of participants with uveitis and iris/pupil abnormality
Number of participants with uveitis and iris/pupil abnormality evaluated based on the slip lamp examination.
IOP
Intraocular pressure measured by the Tono-pen or non-contact tonometer
Secondary outcomes
BCVA change
Change from baseline in the best corrected visual acuity (BCVA) measured by the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.
AL change
Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan
CCT change
Change from baseline in the central corneal thickness (CCT) measured by pentacam.
CFT change
Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT)
Sponsors and contacts
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