Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy

Congenital Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05136209
• Other study ID #: CCPMOH2021-China12
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 1, 2026

Study information

• Verified date: November 2021
• Source: Sun Yat-sen University
• Contact: Tingfeng Qin
• Phone: 13724104066
• Email: qintf3[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

Intervention

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.
• PCCC+A-Vit procedure
PCCC+A-Vit procedure

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with visual axis opacification	Number of participants with visual axis opacification evaluated based on the retro-illumination.	5 years
Primary	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.	5 years
Primary	IOP	Intraocular pressure measured by the Tono-pen or non-contact tonometer	5 years
Secondary	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.	5 years
Secondary	AL change	Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan	5 years
Secondary	CCT change	Change from baseline in the central corneal thickness (CCT) measured by pentacam.	5 years
Secondary	CFT change	Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT)	5 years