Macular Thickness and Visual Acuity in Diabetic Hypertens... | NCT05209971

Studies
Macular Thickness and Visual Acuity in Diabetic Hypertensive Patients

NCT05209971

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jan 27, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Macular Edema

Interventions

Not provided

Countries

Not provided

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

Jan 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

Jan 2022Estimated

Primary Completion Date

Jun 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jan 13, 2022

First Submission Date that Met QC Criteria

Jan 22, 2022

First Posted Date

Jan 27, 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

Jan 22, 2022

Last Update Posted Date

Jan 27, 2022Actual

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

In this study, measurements of central macular thickness using optical coherence tomography along with examination of visual acuity by Snellen's chart in diabetic hypertensive patients will be done .

Detailed Description

correlate relationship between optical coherence tomography changes and visual acuity in patients with type 2 diabetes and hypertension

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

100Estimated

Label	Type	Description	Intervention Names
macular thickness and visual acuity		optical coherence tomography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
macular thickness in diabetic hypertensive patients	measurement of central macular thickness by optical coherence tomography	June 2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetic patients with hypertension .

Exclusion Criteria:

Patients with type 1 diabetes mellitus .
Ocular disease ( such as high myopia , glaucoma ) .
Patients with opacities in the media ( corneal opacities , dense cataract , vitreous hemorrhage ) .
Systemic medication (Tamoxifen , Chloroquine , Canthaxanthine ) to avoid its effect on macular thickness .
Central visual field defect that prevents fixation on OCT .
Intraocular inflammation such as anterior or posterior uveitis .
Refractive error greater than 6 diopter .

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

This is a retrospective study of patients of type 2 diabetes with hypertension

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gamal Abdelateef, professor	Contact	01001244421		raghdaabdelraheem89@gmail.com
Alahmady Hamad, professor	Contact	01111102698		raghdelaysh@gmail.com

Overall Officials

Name	Affiliation	Role
Raghda Abdelraheem, doctor	faculty of medicine	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

measurement of macular thickness

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008269	Macular Edema

Ancestor Terms

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided