Ocular Trauma and COVID-19 in Indonesia | NCT06291844

Studies
Ocular Trauma and COVID-19 in Indonesia

NCT06291844

Sponsor

Prof. R. D. Kandou General Hospital

Status

Completed

Last Update Posted

Mar 4, 2024Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Ophthalmological Disorder
Ocular Injury
COVID-19

Interventions

Not provided

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Mar 31, 2022Actual

Completion Date

Jun 1, 2023Actual

First Submitted Date

Mar 1, 2024

First Submission Date that Met QC Criteria

Mar 1, 2024

First Posted Date

Mar 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2024

Last Update Posted Date

Mar 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vera Sumual, Vera Sumual, MD, PhD, Prof. R. D. Kandou General HospitalPrincipal Investigator

Lead Sponsor

Prof. R. D. Kandou General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ocular injuries, a significant contributor to avoidable blindness globally, impact approximately 55 million individuals each year. Prompt initial treatment is vital for improving vision, yet the scarcity of skilled eye specialists often results in overcrowding at advanced medical centers. Moreover, the COVID-19 outbreak has introduced distinct factors into the management of ocular trauma. This research investigated the epidemiology of ocular injuries during the pandemic and offered observations on the distinctive hurdles and trends encountered.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Measure	Description	Time Frame
Ocular Trauma		2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ocular Trauma Patients presenting between January 2021 to March 2022

Exclusion Criteria:

Presenting on days outside the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Ocular trauma patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Prof. R. D. Kandou General Hospital - Faculty of Medicine, Sam Ratulangi University		Manado	North Sulawesi		Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005128	Eye Diseases
D005131	Eye Injuries
D000086382	COVID-19

Ancestor Terms

ID	Term
D005151	Facial Injuries
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided