Phacovitrectomy Versus Pars Plana Vitrectomy Alone for Post-Intravitreal Injection Endophthalmitis

NCT07717944 | Completed

• 1 other identifier: PPIE-PHACO-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective comparative interventional study evaluated the anatomical and visual outcomes of phacovitrectomy versus pars plana vitrectomy (PPV) alone in patients with post-intravitreal injection endophthalmitis. Eligible patients underwent either combined phacovitrectomy or PPV alone according to the study protocol. The primary outcome was the change in best-corrected visual acuity (BCVA) from baseline to 3 months after surgery. Secondary outcomes included postoperative complications, need for additional surgical intervention, resolution of intraocular inflammation, and restoration of media clarity.

Conditions

Endophthalmitis; Endophthalmitis Postoperative; Intravitreal Injection Patients

Keywords

Post-intravitreal injection endophthalmitis; Vitrectomy; Pars plana vitrectomy; Visual outcomes

Outcome Measures

Primary Outcomes (1)

• Change in Best-Corrected Visual Acuity (BCVA)

  Change in best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR) from baseline to 3 months after surgery. Outcomes will be compared between the phacovitrectomy and pars plana vitrectomy groups.

  Baseline and 3 months after surgery

Secondary Outcomes (1)

• Need for Additional Surgical Intervention

  Up to 3 months after surgery

Study Arms (2)

Phacovitrectomy

EXPERIMENTAL

Twenty participants with post-intravitreal injection endophthalmitis underwent combined phacoemulsification with intraocular lens implantation and pars plana vitrectomy as the primary surgical treatment. Standard intravitreal antibiotics were administered according to the study protocol when indicated.

Procedure: Phacovitrectomy

Pars Plana Vitrectomy Alone

ACTIVE COMPARATOR

Twenty participants with post-intravitreal injection endophthalmitis underwent pars plana vitrectomy alone as the primary surgical treatment. Standard intravitreal antibiotics were administered according to the study protocol when indicated.

Procedure: Pars plana vitrectomy

Interventions

Phacovitrectomy PROCEDURE

Combined phacoemulsification with intraocular lens implantation and standard 23- or 25-gauge pars plana vitrectomy performed as the primary surgical treatment for post-intravitreal injection endophthalmitis. Vitrectomy included removal of vitreous opacities and inflammatory debris with intravitreal administration of antibiotics according to the study protocol.

Also known as: Combined phacoemulsification and pars plana vitrectomy

Phacovitrectomy

Pars plana vitrectomy PROCEDURE

Standard 23- or 25-gauge pars plana vitrectomy performed as the primary surgical treatment for post-intravitreal injection endophthalmitis without simultaneous cataract extraction. Vitrectomy included removal of vitreous opacities and inflammatory debris with intravitreal administration of antibiotics according to the study protocol.

Also known as: PPV

Pars Plana Vitrectomy Alone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Clinical diagnosis of acute post-intravitreal injection infectious endophthalmitis.
• History of intravitreal injection before the onset of endophthalmitis.
• Phakic eye at the time of presentation.
• Eyes with persistent or worsening clinical signs despite initial intravitreal antibiotic therapy (vancomycin and ceftazidime), requiring surgical intervention.
• Underwent either combined phacovitrectomy or pars plana vitrectomy alone as the primary surgical treatment.
• Ability to complete at least 3 months of postoperative follow-up.

You may not qualify if:

• Endophthalmitis secondary to causes other than intravitreal injection (e.g., post-cataract surgery, glaucoma surgery, penetrating ocular trauma, or endogenous endophthalmitis).
• Previous vitrectomy in the study eye.
• Pre-existing ocular conditions likely to significantly affect visual outcomes, including retinal detachment, advanced optic neuropathy, advanced glaucoma, or dense corneal opacity.
• Eyes with no visual potential before the onset of endophthalmitis.
• Inability to complete the scheduled follow-up visits or missing primary outcome data.

Sponsors & Collaborators

• Benha University: lead
• faculty of medicine, Benha university: collaborator

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

Location

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

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 of Ophthalmology

Model Details: Eligible patients with post-intravitreal injection endophthalmitis were assigned to one of two parallel treatment groups. Group A underwent combined phacovitrectomy, and Group B underwent pars plana vitrectomy alone. Participants remained in their assigned treatment group throughout the study, and outcomes were compared between groups.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: January 15, 2024
• Primary Completion: June 19, 2026
• Study Completion: June 20, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

EG (1)