Early Vitrectomy for Endophthalmitis After Cataract Surgery

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249413
• Other study ID #: RC-14-2-02
• Status: Completed
• Start date: January 2, 2015
• Est. completion date: January 15, 2022

Study information

• Verified date: February 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 15, 2022
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Dissociative Disorders
• Endophthalmitis
• Retinal Detachment
• Vitreous Detachment

Intervention

Procedure:
• Early 23-gauge pars-plana vitrectomy
pars-plana vitrectomy for management of acute post-operative endophthalmitis.

Locations

Country	Name	City	State
Egypt	Ophthalmology department, Benha University, EGYPT	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity	Changes in visual acuity from baseline and after early vitrectomy operation.	Baseline and 3 months after intervention.
Secondary	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)	Baseline and 3 months after intervention.