Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSun Yat-sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PCCC procedure without A-vit

    Procedure/Surgery

    In 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/Surgery

    PCCC+A-Vit procedure

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PCCC procedure without A-vitExperimental treatment 1 intervention
Group B: PCCC+A-Vit procedureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with visual axis opacification

Number of participants with visual axis opacification evaluated based on the retro-illumination.

Time frame
5 years
2

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.

Time frame
5 years
3

IOP

Intraocular pressure measured by the Tono-pen or non-contact tonometer

Time frame
5 years

Secondary outcomes

1

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.

Time frame
5 years
2

AL change

Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan

Time frame
5 years
3

CCT change

Change from baseline in the central corneal thickness (CCT) measured by pentacam.

Time frame
5 years
4

CFT change

Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT)

Time frame
5 years

Other outcomes

Sponsors and contacts

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