Optic Nerve Perfusion Following Treatment with Latanopros... | NCT06730516

Studies
Optic Nerve Perfusion Following Treatment with Latanoprost Versus Brimionidin Tartrate

NCT06730516

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Dec 12, 2024Actual

Enrollment

56Actual

Phase

Early Phase 1

Conditions

Glaucoma

Interventions

Latanoprost (Xalatan)
Brimonidine 0.2 %

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

ID	Type	Description	Link
Zagazig University	Registry Identifier	Institutional review board of zagazig university

Status Module

Record Verification Date

Jun 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

Jun 24, 2024Actual

Primary Completion Date

Sep 1, 2024Actual

Completion Date

Oct 1, 2024Actual

First Submitted Date

Dec 6, 2024

First Submission Date that Met QC Criteria

Dec 11, 2024

First Posted Date

Dec 12, 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

Dec 11, 2024

Last Update Posted Date

Dec 12, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral POAG equally divided into two groups with 28 patients in each group. The whole VD was increased and also increased in all four nasal, temporal, superior, and inferior quadrants around optic disc from the initial vessel density before treatment (p<0.001) in both groups significantly with superior improvement in group (1) compared to group (2) that was statistically significant

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Latanoprost (Xalatan)	Experimental	Group (1) included 23 patients (46 eyes) treated with Latanoprost 0.005 %	Drug: Latanoprost (Xalatan)
Brimonidine 0.2%	Experimental	24 patients (48 eyes) received treatment with Brimonidin tartrate 0.2% in group (2)	Drug: Brimonidine 0.2 %

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Latanoprost (Xalatan)	Drug	latanoprost 0.005	Latanoprost (Xalatan)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OPTIC NERVE PERFUSION using OCT angiography numerical analysis system presented in %	perfusion of optic nerve head in patients with primary open angle glaucoma (POAG) using optical coherence tomography angiography (OCTA).	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age more than 18 years newly diagnosed naive patients with POAG

Exclusion Criteria:

optic nerve lesions other than glaucomatous changes patients with previous glaucoma surgery

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yasmine A Deiaeldin, MD	Zagazig University	Study Director
Hani elbialy, MD	Zagazig University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zagazig University		Zagazig	Sharqia Province	44511	Egypt

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
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077338	Latanoprost

Ancestor Terms

ID	Term
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral primary open angle glaucoma equally divided into two groups with 28 patients in each group. Nine patients, five in group (1) and four in group (2) were excluded due to poor quality OCTA images or non-compliance). Group (1) included 23 patients (46 eyes) treated with Latanoprost 0.005 % while 24 patients (48 eyes) received treatment with Brimonidin tartrate 0.2% in group (2).