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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05249413
Other study ID # RC-14-2-02
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
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