ClinicalTrials.gg
CompletedNCT05249413Updated Feb 21, 2022

Early Vitrectomy for Endophthalmitis After Cataract Surgery

An observational study in Endophthalmitis, Cataract and Vitreous Detachment, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-21.

Sponsored by Benha University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
11
Ages
3 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endophthalmitis
  • Cataract
  • Vitreous Detachment
  • Retinal Detachment

Keywords

  • endophthalmitis
  • cataract
  • vitrectomy
  • retinal detachment
03

In context

Endophthalmitis

65 studies on the registry are indexed under Endophthalmitis; 9 are open to participants now.

This study's enrollment of 11 is below the median of 100 across 20 observational studies indexed under Endophthalmitis.

Browse Endophthalmitis studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
11 participants (actual)
Patient registry
No

Groups and cohorts

  • Endophthalmitis after primary cataract surgery.

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

    Procedure: Early 23-gauge pars-plana vitrectomy

Interventions

  • ProcedureEarly 23-gauge pars-plana vitrectomy

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

06

What researchers measure

Primary outcomes

  1. Best-corrected visual acuity

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

    Time frame: Baseline and 3 months after intervention.

Secondary outcomes

  1. Other prognostic factors

    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)

    Time frame: Baseline and 3 months after intervention.

07

Study locations

1 site
  • Ophthalmology department, Benha University, EGYPT
    Banhā, 13511, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2015 to primary completion in Dec 2020, 71 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2022
First posted
Feb 21, 2022
StartActual
Jan 2, 2015
Primary completionActual
Dec 30, 2020
CompletionActual
Jan 15, 2022
Last update
Feb 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05249413
Lead sponsor
Benha University
Responsible party
Ahmed Abdelshafy (Lecturer of Ophthalmology, Benha University) — Principal investigator
First posted
Feb 21, 2022
Start date
Jan 2, 2015
Primary completion
Dec 30, 2020
Completion
Jan 15, 2022
Last update
Feb 21, 2022

Study contacts

Ahmed A Abdelshafy, MD
study chair · Benha University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion