NCT05136209

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Nov 2021Nov 2026

Study Start

First participant enrolled

November 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

5 years

First QC Date

November 11, 2021

Last Update Submit

November 25, 2021

Conditions

Congenital Cataract

Keywords

Congenital cataract surgeryanterior vitrectomypostoperative complications

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • BCVA change

    5 years

  • AL change

    5 years

  • CCT change

    5 years

  • CFT change

    5 years

Study Arms (2)

PCCC procedure without A-vit

EXPERIMENTAL

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

Procedure: PCCC procedure without A-vit

PCCC+A-Vit procedure

ACTIVE COMPARATOR

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

Interventions

PCCC procedure without A-vitPROCEDURE

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 procedure without A-vit
PCCC+A-Vit procedurePROCEDURE

PCCC+A-Vit procedure

PCCC+A-Vit procedure

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Weirong Chen, MD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingfeng Qin

CONTACT

13724104066qintf3@mail2.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 29, 2021

Study Start

November 1, 2021

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

November 29, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)