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Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy

NCT ID: NCT05136209

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2026-11-01

Brief Summary

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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

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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.

Conditions

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Congenital Cataract

Keywords

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Congenital cataract surgery anterior vitrectomy postoperative complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PCCC procedure without A-vit

Procedure/Surgery: PCCC procedure without A-vit ACCC + I / A + PCCC or ACCC + I / A +PCCC + IOL

Group Type EXPERIMENTAL

PCCC procedure without A-vit

Intervention Type 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/Surgery: PCCC+A-Vit procedure ACCC + I / A + PCCC + A-vit or ACCC + I / A +PCCC + IOL + A-vit

Group Type ACTIVE_COMPARATOR

PCCC+A-Vit procedure

Intervention Type PROCEDURE

PCCC+A-Vit procedure

Interventions

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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.

Intervention Type PROCEDURE

PCCC+A-Vit procedure

PCCC+A-Vit procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weirong Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tingfeng Qin

Role: CONTACT

Phone: 13724104066

Email: [email protected]

Facility Contacts

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Tingfeng Qin

Role: primary

Other Identifiers

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CCPMOH2021-China12

Identifier Type: -

Identifier Source: org_study_id