Optic Nerve Course Variants in Nepali Population | NCT06077929

Studies
Optic Nerve Course Variants in Nepali Population

NCT06077929

Sponsor

Grande International Hospital, Nepal

Status

Completed

Last Update Posted

Nov 7, 2024Actual

Enrollment

367Actual

Phase

Not provided

Conditions

Optic Nerve

Interventions

No intervention done

Countries

Nepal

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

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, 2022Actual

Primary Completion Date

May 30, 2023Actual

Completion Date

May 30, 2023Actual

First Submitted Date

Oct 5, 2023

First Submission Date that Met QC Criteria

Oct 5, 2023

First Posted Date

Oct 11, 2023Actual

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

Nov 6, 2024

Last Update Posted Date

Nov 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

PRAJWAL DAHAL, Principal Investigator, Grande International Hospital, NepalPrincipal Investigator

Lead Sponsor

Grande International Hospital, NepalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A retrospective study was conducted on 367 patients. CT PNS and head of the patients were evaluated for type of course of optic nerve according to DeLano's Classification.

Detailed Description

A retrospective study was conducted on 367 patients aged 13 years and above. Four investigators, each with 2 to 6 years of experience in the field of radiology, evaluated computed tomography scans of the paranasal sinuses and the head of these patients. The optic nerves were classified into four types based on DeLano's classification, and their respective prevalence rates were determined. Additionally, the prevalence of optic nerve dehiscence and pneumatization of the anterior clinoid process was assessed.

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

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

367Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rhinosinusitis		Patients with rhinosinusitis	Other: No intervention done

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention done	Other	No interventions done	Rhinosinusitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of different types of optic nerve course	Type 4 course is more prevalent than type 3 course	1.5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Patients undergoing NCCT PNS and Head for chronic rhinosinusitis, headache and vertigo

Exclusion Criteria:

Patient less than 13 years age
Patients with recent trauma
Patient with large mass/ extensive polyposis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

94 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patient of age 13 years and more undergoing NCCT PNS and Head for chronic rhinosinusitis , headache and vertigo

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PRAJWAL DAHAL, MD	Grande International Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prajwal Dahal		Kathmandu	Bagmati	Nepal	Nepal