Early Vitrectomy for Endophthalmitis After Cataract Surgery

Completed

• Conditions: Endophthalmitis; Vitreous Detachment; Retinal Detachment; Cataract
• Interventions: Procedure: Early 23-gauge pars-plana vitrectomy

• Registration Number: NCT05249413
• Lead Sponsor: Benha University

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.

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 Timeline

• Study Start: 2015-01-02
• Primary Completion: 2020-12-30
• Study Completion: 2022-01-15
• Status Verified: 2022-02
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endophthalmitis after primary cataract surgery.	Early 23-gauge pars-plana vitrectomy	Cases diagnosed as acute post-operative endophthalmitis after primary cataract surgery.

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity	Baseline and 3 months after intervention.	Changes in visual acuity from baseline and after early vitrectomy operation.

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Ophthalmology department, Benha University, EGYPT; 🇪🇬 Banhā, Egypt