NCT06990607

Brief Summary

Comparing PPV with and without silicone oil in managing postoperative endophthalmitis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 17, 2025

Last Update Submit

May 17, 2025

Conditions

Endophthalmitis Following Cataract Surgery

Keywords

Postoperative endophthalmitispars plana vitrectomysilicone oil

Outcome Measures

Primary Outcomes (1)

  • visual acuity, with best-corrected visual acuity (BCVA) recorded using LogMAR

    log-MAR value (log of the minimum angle of resolution). Normal visual acuity for most adults is approximately -0.1 on this scale, which is equivalent to 20/16 on a Snellen visual acuity chart.

    1, 2, 4, and 12 weeks postoperatively

Study Arms (2)

Group I

ACTIVE COMPARATOR

Pars plana Vitrectomy Alone

Procedure: Pars plana Vitrectomy

Group II

ACTIVE COMPARATOR

Pars plana Vitrectomy with Silicone Oil

Procedure: Pars plana VitrectomyProcedure: Silicone Oil

Interventions

Pars plana VitrectomyPROCEDURE

Pars plana Vitrectomy using 23 Gauge

Group IGroup II
Silicone OilPROCEDURE

Silicone Oil injection after PPV

Group II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients (≥ 18 years) presenting with clinical manifestations of endophthalmitis after cataract surgery

You may not qualify if:

  • patients with concurrent ocular or systemic conditions that could potentially confound study outcomes, such as active retinal diseases unrelated to endophthalmitis
  • pre-existing poor visual prognosis due to conditions like advanced glaucoma or macular degeneration, or prior ocular surgery affecting the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Silicone Oils

Intervention Hierarchy (Ancestors)

SiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 17, 2025

First Posted

May 25, 2025

Study Start

January 20, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations

EG(1)