NCT03342794

Brief Summary

Few descriptive studies have focused on the anatomical parameters in patients with preexisting PCDs. The characteristics of cataract morphology and anatomical parameters in these patients remained unclear, when compared with CC patients with intact posterior capsule. We conduct the current study to compare the cataract morphology and preoperative parameters, including central corneal thickness, axial length, anterior chamber depth, lens thickness, corneal diameter, keratometry，dialated pupil diameter and intraocular pressure, between CC patients with preexisting PCDs and those with intact posterior capsule, and to explore potential risk factors for preexisting PCDs.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

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

Study Start

First participant enrolled

November 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

November 6, 2017

Last Update Submit

November 9, 2017

Conditions

Congenital Cataract

Outcome Measures

Primary Outcomes (1)

  • lens thickness measured by A-scan ultrasonography

    lens thickness in congenital cataracts with either preexisting posterior capsule defects or intact posterior capsule will be measured by A-scan and compared.

    6 months

Study Arms (1)

preexisting posterior capsule defects

OTHER

congenital cataracts with a preexisting posterior capsule defect

Procedure: cataract surgery

Interventions

cataract surgeryPROCEDURE

To diagnose the preexisting posterior capsule defects in congenital cataracts after the cataracts are removed by surgery and observe the characteristics

preexisting posterior capsule defects

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • congenital cataract

You may not qualify if:

  • incooperative to complete the preoperative examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Zhangliang Li, MD

CONTACT

86-571-88185666lizhangliang0328@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 17, 2017

Study Start

November 1, 2017

Primary Completion

October 1, 2018

Study Completion

August 1, 2019

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)