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NCT Number: NCT05136209

Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Tingfeng Qin

CONTACT

[email protected]

13724104066

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCCC procedure without A-vit

Procedure

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

PCCC+A-Vit procedure

Primary outcomes

  1. Number of participants with visual axis opacification

    Time frame: 5 years

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

  2. Number of participants with uveitis and iris/pupil abnormality

    Time frame: 5 years

    Number of participants with uveitis and iris/pupil abnormality evaluated based on the slip lamp examination.

  3. IOP

    Time frame: 5 years

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

Secondary outcomes

  1. BCVA change

    Time frame: 5 years

    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.

  2. AL change

    Time frame: 5 years

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

  3. CCT change

    Time frame: 5 years

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

  4. CFT change

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Tingfeng Qin

CONTACT

[email protected]

13724104066

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 29, 2021
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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