NCT05938491

Brief Summary

Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR )

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

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

June 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

June 26, 2023

Last Update Submit

July 4, 2023

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • OCT and OCT angiography to assess the macular thickness , outline and vascularity

    Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR ) .

    3 months after surgery

Interventions

OCT and OCT-ADIAGNOSTIC_TEST

OCT and OCT angiography for the macula

Eligibility Criteria

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

patients with complicated proliferative diabetic retinopathy underwent pars plana vitrectomy

You may qualify if:

  • Cases with complicated PDR as persistant vitreous hemorrhage or tractional retinal detachment involving or threatening the macula underwent PPV with or without ILM peeling

You may not qualify if:

  • eyes with media opacity after PPV not allowing imaging of the macula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Central Study Contacts

Omar Abdelkarem Hasan, M.B.B.CH

CONTACT

00201000525341oabdelkarem@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of ophthalmology

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 10, 2023

Study Start

August 1, 2023

Primary Completion

August 1, 2024

Study Completion

January 1, 2025

Last Updated

July 10, 2023

Record last verified: 2023-07