NCT05249413

Brief Summary

Post-operative infectious endophthalmitis is devastating condition that causes a diffuse intraocular inflammation and may lead to blindness. Acute post-operative endophthalmitis usually presented within 6 weeks of intraocular procedure and diagnosis is confirmed by clinical examination and by the aid of B-scan ultrasonography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

6 years

First QC Date

February 10, 2022

Last Update Submit

February 10, 2022

Conditions

Keywords

endophthalmitiscataractvitrectomyretinal detachment

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity

    Changes in visual acuity from baseline and after early vitrectomy operation.

    Baseline and 3 months after intervention.

Secondary Outcomes (1)

  • Other prognostic factors

    Baseline and 3 months after intervention.

Study Arms (1)

Endophthalmitis after primary cataract surgery.

Cases diagnosed as acute post-operative endophthalmitis after primary cataract surgery.

Procedure: Early 23-gauge pars-plana vitrectomy

Interventions

pars-plana vitrectomy for management of acute post-operative endophthalmitis.

Endophthalmitis after primary cataract surgery.

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that were diagnosed as acute post-operative endophthalmitis at ophthalmology department, Benha University Hospital, EGYPT.

You may qualify if:

  • Acute onset endophthalmitis within 6 weeks after primary cataract surgeries.
  • Patients had undergone early pars-plana vitrectomy within 48 hours of their confirmed diagnosis.

You may not qualify if:

  • Patients were diagnosed as endogenous or chronic endophthalmitis.
  • Patients with a previous history of rupture globe surgery or trauma.
  • Patients who didn't complete the follow up period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology department, Benha University, EGYPT

Banhā, 13511, Egypt

Location

MeSH Terms

Conditions

EndophthalmitisCataractVitreous DetachmentRetinal Detachment

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye DiseasesLens DiseasesRetinal Diseases

Study Officials

  • Ahmed A Abdelshafy, MD

    Benha University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 21, 2022

Study Start

January 2, 2015

Primary Completion

December 30, 2020

Study Completion

January 15, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Locations