NCT07726381

Brief Summary

An observational cross-sectional comparative study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt to detect the relation between glycemic control and retinal microvascular changes in diabetic patients using OCTA

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 20, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

retinal microvascular changesdiabetic retinopathyOptical coherence topography

Outcome Measures

Primary Outcomes (1)

  • OCT findings

    OCTA images and data will be collected and analysed from the electronic medical reports for all patients to detect micro-vascular changes in the form of : 1. Vascular density ( superficial and deep plexuses )in square millimeters (mm²). 2. Foveal Avascular Zone ( FAZ ) in percentage

    1 year

Study Arms (1)

This study will include 50 eyes of diabetic patients divided into: Group 1: 25 eyes of diabetic pati

This study will include 50 eyes of diabetic patients divided into: Group 1: 25 eyes of diabetic patients with controlled HbA1c Group 2: 25 eyes of diabetic patients with uncontrolled HbA1c,

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 eyes of diabetic patients with with diabetic retinopathy with controlled and uncontrolled HbA1c

You may qualify if:

  • Diabetic patients with diabetic retinopathy with controlled and uncontrolled HbA1c

You may not qualify if:

  • Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous opacities, etc).
  • Patients with any other retinal vascular diseases (retinal vein occlusion, central serrous chorioretinopathy, age-related macular degeneration, etc).
  • Patients who have had previous intravitreal injections or Laser treatment.
  • Patients who underwent previous vitreoretinal surgeries.
  • Patients with recent history of undergoing cataract surgery.
  • Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Al Ahmady Al Samman, Professor

    Faculty of Medicine, Sohag university

    STUDY DIRECTOR
  • Hany Mahmoud, Assist.Prof

    Faculty of Medicine, Sohag university

    STUDY DIRECTOR

Central Study Contacts

Sara Mahmoud, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rediant of Opthalmology department

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 24, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

July 24, 2026

Record last verified: 2026-07