Early Vitrectomy for Endophthalmitis After Cataract Surgery

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT05249413
Collaborator
(none)
11
1
84.4
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Early 23-gauge pars-plana vitrectomy

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 Design

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Outcomes of Early Vitrectomy for Endophthalmitis After Cataract Surgery in Delta Population, Egypt, 2015-2020.
Actual Study Start Date :
Jan 2, 2015
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Jan 15, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Best-corrected visual acuity [Baseline and 3 months after intervention.]

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

Secondary Outcome Measures

  1. Other prognostic factors [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ophthalmology department, Benha University, EGYPT Banhā Egypt 13511

Sponsors and Collaborators

  • Benha University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
ClinicalTrials.gov Identifier:
NCT05249413
Other Study ID Numbers:
  • RC-14-2-02
First Posted:
Feb 21, 2022
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2022