Perfluorooctyl Bromide Which Empowers the Liquid to Flat... | NCT05699096

Studies
Perfluorooctyl Bromide Which Empowers the Liquid to Flat the Detached Retina and Displace the Underneath Fluids Anteriorly

NCT05699096

Sponsor

EL Romany Ophthalmics Factory

Status

Unknown status

Last Update Posted

Jul 3, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Retinal Disease

Interventions

Not provided

Countries

Egypt

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

Jun 2024

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

Sep 1, 2024Estimated

Primary Completion Date

Jul 1, 2025Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Jan 15, 2023

First Submission Date that Met QC Criteria

Jan 24, 2023

First Posted Date

Jan 26, 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

Jun 30, 2024

Last Update Posted Date

Jul 3, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Perfluorohexyloctaneis Essential for Repositioning Giant Retinal Breaks and Can be Used for Removal of Subretinal Fluid as Well as Stabilization of the Retina to Offset

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

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

20Estimated

Label	Type	Description	Intervention Names
eye surgery ,Vitreoretinal Surgery and Related Ocular Inflammation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
flat the detached retina and displace the underneath fluids anteriorly	the effect of Perfluorooctyl Bromide on the retina ,under ophthalmic microscope check the flatted retina	Base line

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;

Exclusion Criteria:

Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
El R Ophthalmics	Contact	+201212331343		drmina@elromanyophthalmics.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Girgis Boules	Recruiting	Cairo	Kubri EL Kubba	11711	Egypt