SD-OCT Guided Treatment of Fungal Chorioretinitis | NCT04947592

Studies
SD-OCT Guided Treatment of Fungal Chorioretinitis

NCT04947592

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Dec 15, 2021Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Fungal Retinitis

Interventions

Fluconazole 150 mg

Countries

United Arab Emirates

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2020Actual

Primary Completion Date

Jan 2022Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Jun 24, 2021

First Submission Date that Met QC Criteria

Jun 24, 2021

First Posted Date

Jul 1, 2021Actual

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

Dec 14, 2021

Last Update Posted Date

Dec 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarek Roshdy mohamed Mahgoub ELhamaky, Associate Professor, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Fungal Chorioretinitis is a vision threatening condition.The investigators evaluate the efficacy of SD-OCT role in the treatment

Detailed Description

Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination and SD-OCT was done.Procedure included oral fluconazole treatment 1 tablet once for 14 days

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluconazole 150 mg	Drug	fluconazole 150 MG once daily for 14 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity (BCVA)	Change in BCVA in LOG MARS(logarithm minimum angle of resolution	6 months

Secondary Outcomes

Measure	Description	Time Frame
optical coherence tomography (OCT) foveal thickness	change in foveal thickness measured in micrometer	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- fungal chorioretinitis

Exclusion Criteria:

vitritis
other macular lesion
macular scar

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

at least 18 years old patient with fungal chorioretinitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
TAREK R ELHAMAKY, MD	Contact	0503207889		thamaky@ibnnafees.com
TAREK ELHAMAKY	Contact	0503207889		thamaky@ibnnafees.com

Overall Officials

Name	Affiliation	Role
TAREK ELHAMAKY	Benha University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INMC	Recruiting	Abu Dhabi		46266	United Arab Emirates

Condition Browse Module

MeSH Terms

ID	Term
D002825	Chorioretinitis

Ancestor Terms

ID	Term
D012173	Retinitis
D012164	Retinal Diseases
D005128	Eye Diseases
D002833	Choroiditis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015725	Fluconazole

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided