Retinal Vascular Changes in Primary Open Angle Glaucoma P... | NCT05351307

Studies
Retinal Vascular Changes in Primary Open Angle Glaucoma Patients

NCT05351307

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Apr 28, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Primary Open Angle Glaucoma

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Estimated

Primary Completion Date

Apr 1, 2023Estimated

Completion Date

Jun 1, 2023Estimated

First Submitted Date

Apr 24, 2022

First Submission Date that Met QC Criteria

Apr 27, 2022

First Posted Date

Apr 28, 2022Actual

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

Apr 27, 2022

Last Update Posted Date

Apr 28, 2022Actual

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

the study aims to detect ischemic changes in macula using OCT angiography in primary open angle glaucoma patients correlating with glaucoma staging system II by visual field.

Detailed Description

Our study will be designed as " prospective non-randomized case - control study" The study will include 100 eyes of 100 participants 50 eyes of normal subjects , non-glaucomatous subjects 50 eyes of 50 patients with POAG To detect ischemic changes in macula using OCT angiography correlating with glaucoma staging system II by visual field.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POAG patients		OCT angiography will be performed
Normal participants		OCT angiography will be performed

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ischemic changes in macula	Using OCT angiography to detect ischemic changes in macula	Through one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(> 18 years old)

Exclusion Criteria:

patients with cataract
retinal disorders including: AMD , Macular degeneration , retinal detachment , retinitis pigmentosa , etc .
corneal opacites
any ocular surgeries
patients with systemic disease.
patient refusal

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

> 18 years primary open angle glaucoma patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marwa Hamza, Resident	Contact	01018421051		Marwahamza12@yahoo.com
Ismail Moussa Abd-Elatif, Professor	Contact

Overall Officials

Name	Affiliation	Role
Mohamed Iqbal Hafez, Assist prof	Supervisor	Study Director
Hany Mahmoud Abdel Hamid, Lecturer	Supervisor	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University hospitals		Sohag			Egypt

Type	Date	Date Unknown
Release	Feb 7, 2024
Reset	Jul 19, 2024

Submission Tracking

Estimated Results First Submitted Date

Feb 7, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 7, 2024			Jul 19, 2024

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided