NCT04077489

Brief Summary

Congenital cataract is the main cause of form deprivation amblyopia in children. Current studies confirm that form deprivation amblyopia affects the macular development. However, there are different opinions about the effect of amblyopia on the macular thickness . Investigators have performed "cataract extraction with IOL implantation" on children with bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure children's the macular thickness before and after surgery..Average sectional total thickness was automatically determined by the instrument's software using a modified Early Treatment Diabetic Retinopathy Study (ETDRS) circle grid (fovea, inner ring, and outer ring: 1 mm, 3 mm, and 6 mm. Investigators dynamically observed changes in macular to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.

Trial Health

87
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
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

August 3, 2019

Last Update Submit

September 2, 2019

Conditions

MacularCongenital Cataract

Keywords

macular thickness

Outcome Measures

Primary Outcomes (1)

  • macular thickness

    macular thickness changes before and after cataract surgery

    6 months

Study Arms (1)

MT

OTHER

Macular thickness

Procedure: cataract surgery

Interventions

cataract surgeryPROCEDURE

To measure the MT in congenital cataracts before and after the cataract extraction with IOL implantation surgery

MT

Eligibility Criteria

Age1 Month - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • congenital cataract

You may not qualify if:

  • incooperative to complete the preoperative and postoperative examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TianTong

Beijing, China

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Yin Ying Zhao

Study Record Dates

First Submitted

August 3, 2019

First Posted

September 4, 2019

Study Start

January 1, 2016

Primary Completion

November 1, 2018

Study Completion

August 1, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

CN(1)