NCT04323982

Brief Summary

Previously, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. This prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior vitreous in treating congenital cataracts.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 27, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

March 25, 2020

Last Update Submit

June 2, 2020

Conditions

Congenital Cataract

Keywords

congenital cataract, Triamcinolone

Outcome Measures

Primary Outcomes (3)

  • incidence of high intraocular pressure

    Determined with the Tono-pen.

    5 years

  • incidence of visual axis opacification

    Visual axis obscuration will be evaluated based on the retroillumination.

    5 years

  • incidence of uveitis and iris/pupil abnormality

    Uveitis and iris/pupil abnormality will be evaluated based on the slip lamp examination.

    5 years

Secondary Outcomes (3)

  • Best corrected visual acuity

    5 years

  • Central corneal thickness

    5 years

  • Central macular thickness

    5 years

Study Arms (2)

New Cataract Surgery

EXPERIMENTAL

Traditional surgery combined triamcinolone staining of the anterior vitreous (TA)

Procedure: new surgical procedure

Traditional Cataract Surgery

ACTIVE COMPARATOR

For patients younger than 2 years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + A-vit) For patients older than 2years of age: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + primary intraocular lens implantation + anterior vitrectomy (ACCC+ I/A + PCCC + IOL + A-vit)

Procedure: traditional surgical procedure

Interventions

new surgical procedurePROCEDURE

（ACCC + I / A + PCCC + TA+ A-vit) or （ACCC + I / A + PCCC + IOL + TA + A-vit）

New Cataract Surgery
traditional surgical procedurePROCEDURE

（ACCC + I / A + PCCC + A-vit) or （ACCC + I / A + PCCC + IOL + A-vit）

Traditional Cataract Surgery

Eligibility Criteria

Age3 Months - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 3 months and 13 years
  • Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity)
  • Informed consent signed by a parent or legal guardian

You may not qualify if:

  • Intraocular pressure \>21 mmHg
  • Preterm birth (\<28 weeks)
  • Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy)
  • History of ocular trauma
  • Previous intraocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Links

Study Officials

  • Chen Weirong, MD

    SunYat-sen University

    STUDY CHAIR

Central Study Contacts

Wang Qiwei, MD

CONTACT

+86-13924025677wang_qiwei@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

March 27, 2020

Primary Completion

March 25, 2021

Study Completion

March 25, 2021

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)