Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Cataract
• Intervention / Treatment: Procedure: PCCC procedure without A-vit; Procedure: PCCC+A-Vit procedure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tingfeng Qin; Phone Number: 13724104066; Email: qintf3@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Tingfeng Qin; Phone Number: 13724104066; Email: qintf3@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCCC procedure without A-vit; Procedure/Surgery: PCCC procedure without A-vit ACCC + I / A + PCCC or ACCC + I / A +PCCC + IOL	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.
Active Comparator: PCCC+A-Vit procedure; Procedure/Surgery: PCCC+A-Vit procedure ACCC + I / A + PCCC + A-vit or ACCC + I / A +PCCC + IOL + A-vit	Procedure: PCCC+A-Vit procedure; PCCC+A-Vit procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with visual axis opacification	Number of participants with visual axis opacification evaluated based on the retro-illumination.	5 years
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
IOP	Intraocular pressure measured by the Tono-pen or non-contact tonometer	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
AL change	Change from baseline in axial length measured by AL-Scan, IOLMaster or A-scan	5 years
CCT change	Change from baseline in the central corneal thickness (CCT) measured by pentacam.	5 years
CFT change	Change from baseline in the central foveal thickness (CFT) measured by Optical Coherence Tomography (OCT)	5 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Weirong Chen, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): November 1, 2026
• Study Completion (Anticipated): November 1, 2026

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): November 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: postoperative complications; Congenital cataract surgery; anterior vitrectomy
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CCPMOH2021-China12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No