NCT05209971

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

January 13, 2022

Last Update Submit

January 22, 2022

Conditions

Macular Edema

Keywords

Macular thickness and visual acuity

Outcome Measures

Primary Outcomes (1)

  • macular thickness in diabetic hypertensive patients

    measurement of central macular thickness by optical coherence tomography

    June 2022

Study Arms (1)

macular thickness and visual acuity

optical coherence tomography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Type 2 diabetic patients with hypertension .

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Raghda Abdelraheem, doctor

    faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamal Abdelateef, professor

CONTACT

01001244421raghdaabdelraheem89@gmail.com

Alahmady Hamad, professor

CONTACT

01111102698raghdelaysh@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 27, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

measurement of macular thickness