NCT03240796

Brief Summary

This prospective, non-randomized controlled study aiming at comparing the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts after the patient receives secondary intraocular artificial lens (IOL) implantation.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

July 26, 2017

Last Update Submit

April 9, 2019

Conditions

Congenital Cataract

Keywords

congenital cataractintra-capsular IOL implantationciliary sulcus fixation

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity

    measured using the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according to the patient's age.

    recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)

Secondary Outcomes (3)

  • Visual axis opacification

    recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)

  • High intraocular pressure

    recorded at each follow-up (one week, one month, three months, six months after surgery, and every six months thereafter)

  • Bi-ocular visual function

    The examination is performed when the patient is four years old and older, once a year.

Study Arms (2)

minimal invasive surgery and secondary IOL implantation

EXPERIMENTAL
Procedure: minimal invasive surgery and secondary IOL implantation

traditional cataract surgery and secondary IOL implantation

ACTIVE COMPARATOR
Procedure: traditional cataract surgery and secondary IOL implantation

Interventions

minimal invasive surgery and secondary IOL implantationPROCEDURE

We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter and moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities. Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.

minimal invasive surgery and secondary IOL implantation
traditional cataract surgery and secondary IOL implantationPROCEDURE

traditional cataract surgery: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit). Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.

traditional cataract surgery and secondary IOL implantation

Eligibility Criteria

Age24 Months - 72 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 24 months and 72 months Uncomplicated congenital cataract and underwent cataract removal Informed consent signed by a parent or legal guardian

You may not qualify if:

  • Intraocular pressure \>21 mmHg at enrollment Preterm birth (\<28 weeks) Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy) History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family History of ocular trauma Microcornea Persistent hyperplastic primary vitreous Rubella Lowe syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center,Sun Yat-sen U

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

  • Haotian Lin, M.D,Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Li, M.D

CONTACT

+86-20-87330341Reviewborad_SYsU@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 7, 2017

Study Start

August 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

CN(1)