Early Vitrectomy for Endophthalmitis After Cataract Surgery

February 10, 2022 updated by: Ahmed Abdelshafy, Benha University

Outcomes of Early Vitrectomy for Endophthalmitis After Cataract Surgery in Delta Population, Egypt, 2015-2020.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is no consensus regarding the timing of vitrectomy in cases with endophthalmitis after cataract surgery. The Endophthalmitis Vitrectomy Study concluded that vitrectomy should be preserved for cases with only light perception. The advances in posterior segment machines and small gauge cannulas decrease the incidence of intra-operative complications and encourage for early intervention in cases with endophthalmitis after primary cataract surgery.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banhā, Egypt, 13511
        • Ophthalmology department, Benha University, EGYPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endophthalmitis after primary cataract surgery.
Cases diagnosed as acute post-operative endophthalmitis after primary cataract surgery.
Procedure: Early 23-gauge pars-plana vitrectomy
pars-plana vitrectomy for management of acute post-operative endophthalmitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best-corrected visual acuity
Time Frame: Baseline and 3 months after intervention.
Changes in visual acuity from baseline and after early vitrectomy operation.
Baseline and 3 months after intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other prognostic factors
Time Frame: Baseline and 3 months after intervention.
Other factors that may influence the final visual outcome in cases with endophthalmitis as (intraocular tamponade, posterior vitreous detachment, systemic condition and virulence of causative organism)
Baseline and 3 months after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Study Chair: Ahmed A Abdelshafy, MD, Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2015

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

January 15, 2022

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-14-2-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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