NCT05140304

Brief Summary

Study and assessment of characteristic changes in foveal avascular zone during different stages of diabetic retinopathy using OCTA.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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

First Submitted

Initial submission to the registry

November 17, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

November 17, 2021

Last Update Submit

November 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean area of FAZ in various stages of diabetic retinopathy and difference between these groups in superficial and deep capillary plexuses

    analysis of foveal avascular zone in different stages of diabetic retinopathy using OCT angiography

    baseline

Study Arms (1)

A

OTHER
Device: OCT angiography

Interventions

OCT angiography of foveal avascular zone in diabetic retinopathy

A

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients suffering from different stages of diabetic retinopathy.

You may not qualify if:

  • Other ocular problems affecting vision including glaucoma, cataract, amblyopia, hypertensive retinopathy, vein occlusion and uveitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kim DY, Fingler J, Zawadzki RJ, Park SS, Morse LS, Schwartz DM, Fraser SE, Werner JS. Optical imaging of the chorioretinal vasculature in the living human eye. Proc Natl Acad Sci U S A. 2013 Aug 27;110(35):14354-9. doi: 10.1073/pnas.1307315110. Epub 2013 Aug 5.

  • Choi W, Mohler KJ, Potsaid B, Lu CD, Liu JJ, Jayaraman V, Cable AE, Duker JS, Huber R, Fujimoto JG. Choriocapillaris and choroidal microvasculature imaging with ultrahigh speed OCT angiography. PLoS One. 2013 Dec 11;8(12):e81499. doi: 10.1371/journal.pone.0081499. eCollection 2013.

  • NOVOTNY HR, ALVIS DL. A method of photographing fluorescence in circulating blood in the human retina. Circulation. 1961 Jul;24:82-6. doi: 10.1161/01.cir.24.1.82. No abstract available.

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Ziad Hn El Daly, MD

    Assuit Universoty

    STUDY CHAIR

Central Study Contacts

Kareem Md Ali, Resident

CONTACT

Ziad Hn El Daly, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 1, 2021

Study Start

November 30, 2021

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

December 1, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share