NCT04383860

Brief Summary

The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

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, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

May 7, 2020

Last Update Submit

June 14, 2021

Conditions

Surgery--ComplicationsRetinoblastoma Bilateral

Keywords

Retinoblastomasuturecomplications

Outcome Measures

Primary Outcomes (1)

  • Rate of participants with complications

    complications, such as orbital implant exposure in the follow-up visit

    2 year after surgery

Study Arms (2)

5-0 suture

EXPERIMENTAL

5-0 suture administration during surgery

Procedure: 5-0 suture

4-0 suture

ACTIVE COMPARATOR

4-0 suture administration during surgery

Procedure: 4-0 suture

Interventions

5-0 suturePROCEDURE

5-0 suture administration during surgery

Also known as: 5-0 suture administration
5-0 suture
4-0 suturePROCEDURE

4-0 suture administration during surgery

Also known as: 4-0 suture administration
4-0 suture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed as retinoblastoma
  • enucleation and orbital implantation in the same surgery

You may not qualify if:

  • death during follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Study Officials

  • Huijing Ye

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

January 1, 2015

Primary Completion

December 31, 2017

Study Completion

July 1, 2020

Last Updated

June 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share