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Recruiting NCT05136209

Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy

No phase Interventional Congenital Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCCC procedure without A-vit, PCCC+A-Vit procedure.
Who it may be relevant to
Registry conditions: Congenital Cataract. Basic parameters: 1 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy in Congenital Cataract Surgery

Overview

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.

Detailed description

Due to the particularity of children's eye structure, selecting the appropriate surgical approach for congenital cataracts presents challenging for ophthalmologists. The major concerned postoperative problem is the after-cataract formation. As a result, PCCC with A-Vit is usually performed to prevent the formation of secondary cataracts. However. Debate over the indication and surgical procedure still persists since A-Vit and excessive manipulations may interfere with the development of the eye and increase the risk of postoperative inflammation, unstable intraocular pressure, macular edema, retinal detachment and so on. Thus, it is necessary to evaluate the safety and effectiveness of PCCC without A-Vit in congenital cataract surgery.

In this randomized clinical trial, children with equal degree of congenital cataract in both eyes are enrolled. 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 includes anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), PCCC, and A-Vit. Primary intraocular lens implantation (IOL) is performed in children older than age of two. Investigators then compare the incidence of visual axis opacity, uveitis, iris/pupil abnormality and intraocular pressure between two groups.

Interventions

  • Procedure PCCC procedure without A-vit
    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.
  • Procedure PCCC+A-Vit procedure
    PCCC+A-Vit procedure

Primary outcome measures

  • Number of participants with visual axis opacification [Time frame: 5 years]
  • Number of participants with uveitis and iris/pupil abnormality [Time frame: 5 years]
  • IOP [Time frame: 5 years]
Secondary outcome measures (4)
  • BCVA change [Time frame: 5 years]
  • AL change [Time frame: 5 years]
  • CCT change [Time frame: 5 years]
  • CFT change [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • 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
  • Have signed a consent form
  • Can be followed

Exclusion criteria

  • Intraocular pressure >21 mmHg
  • History of ocular trauma and intraocular surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT05136209 · CCPMOH2021-China12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗