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CompletedNCT07717944Updated Jul 21, 2026

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

An interventional study of Phacovitrectomy and Pars plana vitrectomy in Endophthalmitis, Endophthalmitis Postoperative and Intravitreal Injection Patients, sponsored by Benha University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Benha University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jan 2024, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

Post-intravitreal injection endophthalmitis is a rare but vision-threatening complication that requires prompt surgical intervention to maximize visual recovery. Pars plana vitrectomy (PPV) is the standard surgical treatment for severe cases; however, whether combining cataract extraction with vitrectomy provides superior anatomical and functional outcomes remains uncertain.

This prospective comparative interventional study was conducted to compare phacovitrectomy with PPV alone in the management of post-intravitreal injection endophthalmitis. Consecutive eligible phakic patients presenting with post-intravitreal injection endophthalmitis were enrolled between 2024 and June 2026 and underwent one of the two surgical approaches according to the study protocol.

Baseline demographic and clinical data were collected, including age, sex, indication for the original intravitreal injection, presenting best-corrected visual acuity (BCVA), clinical findings, microbiological results, and the interval between symptom onset and surgery. Operative details and postoperative follow-up data were prospectively recorded.

The primary outcome measure was the change in BCVA (logMAR) from baseline to 3 months after surgery. Secondary outcome measures included postoperative complications (such as retinal detachment, hypotony, persistent corneal edema, and recurrent infection), the need for additional surgical interventions, resolution of intraocular inflammation, restoration of media clarity, and anatomical success.

Comparative analyses were performed between the two treatment groups using appropriate statistical methods. Multivariable analyses were used to adjust for potential confounding factors, including baseline visual acuity, microbiological culture results, and time from presentation to surgery. The study aimed to determine whether combined phacovitrectomy provides superior visual and anatomical outcomes compared with PPV alone in patients with post-intravitreal injection endophthalmitis.

02

Conditions studied

  • Endophthalmitis
  • Endophthalmitis Postoperative
  • Intravitreal Injection Patients

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Keywords

  • Post-intravitreal injection endophthalmitis
  • Vitrectomy
  • Pars plana vitrectomy
  • Visual outcomes
03

In context

Endophthalmitis

55 studies on the registry are indexed under Endophthalmitis; 8 are open to participants now.

This study's enrollment of 40 is below the median of 113 across 32 interventional studies indexed under Endophthalmitis.

Browse Endophthalmitis studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Phacovitrectomy

    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

  • Active comparator
    Pars Plana Vitrectomy Alone

    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

  • ProcedurePhacovitrectomy

    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

  • ProcedurePars plana vitrectomy

    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

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What researchers measure

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.

    Time frame: Baseline and 3 months after surgery

Secondary outcomes

  1. Need for Additional Surgical Intervention

    Number of participants requiring additional vitreoretinal surgery or other ocular surgical intervention following the initial procedure.

    Time frame: Up to 3 months after surgery

07

Study locations

1 site
  • Benha University
    Banhā, Benha 13111, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07717944
Lead sponsor
Benha University
Collaborators
faculty of medicine, Benha university
Responsible party
Ehab Mohamed Elsayed Mohamed Saad (Lecturer of Ophthalmology, Benha University) — Principal investigator
First posted
Jul 21, 2026
Start date
Jan 15, 2024
Primary completion
Jun 19, 2026
Completion
Jun 20, 2026
Last update
Jul 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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