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EndophthalmitisNCT07888205

Vitrectomy Combined With Povidone-Iodine Vitreous Irrigation for Infectious Endophthalmitis

A study testing Povidone-iodine intravitreal irrigation with povidone-iodine containing 0.0025% available iodine and BSS intravitreal irrigation solution in people with Endophthalmitis and Infectious Endophthalmitis, run by Beijing Tongren Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Infectious endophthalmitis is a severe infection inside the eye that can rapidly cause permanent vision loss or loss of the eye. Standard treatment usually includes vitrectomy, a surgical procedure that removes infected vitreous gel, together with antibiotics. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Endophthalmitis, Infectious Endophthalmitis
What is being tested?
Povidone-iodine intravitreal irrigation with povidone-iodine containing 0.0025% available iodine and BSS intravitreal irrigation solution
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
No sites listed yet
Study dates
30 Oct 2026to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The clinical diagnosis is infectious endophthalmitis, including postoperative endophthalmitis, post-traumatic endophthalmitis, endogenous endophthalmitis, etc.
  • The tested eyes presented with clinical manifestations of endophthalmitis such as red eyes, eye pain, decreased vision, anterior chamber inflammation, and vitreous opacity.
  • The researchers determined that the condition required vitrectomy and standard anti-infection treatment.
  • The subject himself/herself or his/her legal representative signs the informed consent form.
  • Be able to complete the follow-up as required by the plan.

Who cannot join

  • People who are allergic to povidone-iodine or its components.
  • Those with severe underlying eye diseases that significantly affect the determination of the primary outcome, such as advanced macular degeneration, end-stage glaucoma, and severe retinal degeneration, etc.
  • Pregnant or lactating women.
  • Those with severe immunosuppression or extremely poor overall condition who cannot tolerate surgery.
  • Those with confirmed retinal detachment (RD) at the first diagnosis
  • Those who have recently participated in other interventional clinical studies and may affect the outcomes of this study.
  • Other circumstances that the researchers consider unsuitable for enrollment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yanyun Chen, M. D. contact

010-58268430

yanyun_chen@ccmu.edu.cn

About this study

Official title: A Randomized Controlled Trial of Vitrectomy Combined With Povidone-Iodine Vitreous Irrigation for Infectious Endophthalmitis

Infectious endophthalmitis is a severe infection inside the eye that can rapidly cause permanent vision loss or loss of the eye. Standard treatment usually includes vitrectomy, a surgical procedure that removes infected vitreous gel, together with antibiotics. However, infection may remain difficult to control, particularly when the causative microorganism is unknown or resistant to commonly used antibiotics.

Povidone-iodine is a broad-spectrum antiseptic that acts rapidly against many types of bacteria, fungi, and other microorganisms. It is routinely used to disinfect the surface of the eye before surgery, but its use inside the eye for treating established infection is still investigational.

Read more

The purpose of this study is to determine whether brief irrigation of the vitreous cavity with a low concentration of povidone-iodine can improve infection control when added to standard vitrectomy and antimicrobial treatment. The main question is whether irrigation with povidone-iodine containing 0.0025% available iodine increases the proportion of patients whose infection is controlled by 14 days without silicone oil tamponade, compared with irrigation using standard balanced salt solution alone.

This is a single-center, prospective, randomized, parallel-group clinical study involving approximately 38 patients with infectious endophthalmitis. Participants will be assigned in a 1:1 ratio according to the severity of inflammation at enrollment. After vitrectomy has been completed, patients in the study group will receive vitreous cavity irrigation with povidone-iodine containing 0.0025% available iodine for 2 minutes. The solution will then be removed from the eye. Patients in the control group will undergo the same surgical procedure using balanced salt solution without povidone-iodine. Both groups will otherwise receive appropriate standard antimicrobial treatment and clinical care.

The study hypothesis is that brief exposure to low-concentration povidone-iodine will rapidly reduce the number of microorganisms remaining in the eye and improve infection control without causing clinically significant damage to the retina, cornea, or other eye structures.

In addition to the primary outcome of infection control at Day 14 without silicone oil tamponade, the study will evaluate several secondary outcomes,including changes in best-corrected visual acuity, the need for additional eye surgery, and vision-related quality of life. Safety outcomes will include changes in retinal function measured by electroretinography, retinal structure assessed by optical coherence tomography, corneal endothelial cell density, intraocular pressure, and the occurrence and severity of adverse events throughout follow-up.

Being tested
Povidone-iodine intravitreal irrigation with povidone-iodine containing 0.0025% available iodine, BSS intravitreal irrigation solution
Keywords
Infectious Endophthalmitis, Povidone-Iodine, Vitrectomy, Intravitreal Irrigation, Randomized Controlled Trial
Medical subject headings
Endophthalmitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Povidone-iodine intravitreal irrigation with povidone-iodine containing 0.0025% available iodineProcedure or surgery

    After the vitrectomy was completed, povidone-iodine intravitreal irrigation with povidone-iodine containing 0.0025% available iodine was used for 2 minutes.The solution will then be removed from the eye.

  • BSS intravitreal irrigation solutionProcedure or surgery

    After vitrectomy, balanced salt solution (BSS) without povidone-iodine was used for intravitreal irrigation.

Study groups in NCT07888205
Study groupRoleWhat they receive
PI Irrigation GroupExperimentalStandard Pars Plana Vitrectomy combined with intravitreal irrigation using povidone-iodine containing 0.0025% available iodine solution for 2 minutes after vitrectomy completion. Standard perioperative anti-infective treatment applied. Silicone oil tamponade is strictly on demand.
Receives: Procedure: Povidone-iodine intravitreal irrigation with povidone-iodine containing 0.0025% available iodine
Standard BSS GroupActive comparatorStandard Pars Plana Vitrectomy with intraoperative Balanced Salt Solution (BSS) irrigation (PI-free). Standard perioperative anti-infective treatment applied identically to the experimental arm. Silicone oil tamponade is strictly on demand.
Receives: Procedure: BSS intravitreal irrigation solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infection control rate without silicone oil tamponade

    The infection control rate of the patient without silicone oil tamponade 14 days after the operation

    Measured: Day 14

Secondary outcomes (1)
  1. Best-Corrected Visual Acuity (BCVA) Change

    Change in LogMAR BCVA from baseline to post-op follow-up points.

    Measured: Baseline, Day 7, Month 1, Month 3, and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07888205
Sponsor's protocol ID
TREC2026-KY198
Status last verified
Sep 2026
First submitted
14 Oct 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee SM, Lee S, Chae WJ, Park HS. Comparison of Clinical Outcomes of Intravitreal 0.625% Povidone-Iodine versus Antibiotic Injection for Postoperative Endophthalmitis. Korean J Ophthalmol. 2026 Jun;40(3):301-307. doi: 10.3341/kjo.2025.0147. Epub 2026 Mar 4.

    PubMed 41776375
  • Mi X, Malbin B, Lin X. Intraocular Povidone Iodine During Pars Plana Vitrectomy for Severe and Atypical Endophthalmitis. Ophthalmic Surg Lasers Imaging Retina. 2021 Sep;52(9):485-490. doi: 10.3928/23258160-20210820-01. Epub 2021 Sep 1.

    PubMed 34505805
  • Kitagawa Y, Shimada H, Nakashizuka H, Hattori T, Yamazaki Y. Intraocular lens implantation and vitrectomy using 0.025% povidone-iodine in irrigation solution for bleb-related endophthalmitis. Int J Ophthalmol. 2020 Sep 18;13(9):1499-1502. doi: 10.18240/ijo.2020.09.24. eCollection 2020. No abstract available.

    PubMed 32953592
  • Nakashizuka H, Shimada H, Hattori T, Tanaka K, Kitagawa Y, Shinoda K. Intravitreal Injection of 1.25% Povidone Iodine Followed by Vitrectomy Using 0.025% Povidone Iodine Irrigation for Treating Endophthalmitis. Transl Vis Sci Technol. 2019 Feb 13;8(1):21. doi: 10.1167/tvst.8.1.21. eCollection 2019 Jan.

    PubMed 30783556
  • Nakashizuka H, Shimada H, Hattori T, Noguchi T, Kokubo N, Yuzawa M. Vitrectomy using 0.025% povidone-iodine in balanced salt solution plus for the treatment of postoperative endophthalmitis. Retina. 2015 Jun;35(6):1087-94. doi: 10.1097/IAE.0000000000000634.

    PubMed 25946690
  • Machida Y, Nakashizuka H, Onoe H, Kitagawa Y, Nakagawa N, Miyata K, Yamakawa M, Wakatsuki Y, Tanaka K, Mori R, Shimada H. Intravitreal Povidone-Iodine Injection and Low-Dose Antibiotic Irrigation for Infectious Endophthalmitis: A Retrospective Case Series. Pharmaceutics. 2025 Jul 31;17(8):995. doi: 10.3390/pharmaceutics17080995.

    PubMed 40871017
  • Kim KH, Cao J, Yoo JW, Yoon IS, Jung JW, Lee JE, Byon IS. Intraocular Pharmacokinetics of Povidone-Iodine and Its Effects on Experimental Staphylococcus epidermidis Endophthalmitis. Invest Ophthalmol Vis Sci. 2015 Oct;56(11):6694-700. doi: 10.1167/iovs.15-17739.

    PubMed 26469754
  • Shimada H, Kato K, Ishida K, Yamaguchi T, Shinoda K. Evaluation of Retinal Function and Pathology After Intravitreal Injection of Povidone-Iodine and Polyvinyl Alcohol-Iodine in Rabbits. Transl Vis Sci Technol. 2020 Apr 15;9(5):5. doi: 10.1167/tvst.9.5.5. eCollection 2020 Apr.

    PubMed 32821477
  • Soleimani M, Haydar AA, Cheraqpour K, Zeidabadinejad H, Esfandiari A, Eshaghhosseiny N, Shahmohammadi A, Banz S, Djalilian AR. In praise of povidone-iodine application in ophthalmology. Surv Ophthalmol. 2024 Mar-Apr;69(2):211-223. doi: 10.1016/j.survophthal.2023.11.002. Epub 2023 Nov 8.

    PubMed 37944600
  • Tanaka H, Nakashizuka H, Mizuno Y, Hattori T. Endogenous Endophthalmitis successfully treated with Intravitreal Povidone-iodine injection: a case report. BMC Ophthalmol. 2020 Jun 5;20(1):217. doi: 10.1186/s12886-020-01487-w.

    PubMed 32503467
  • Meehan JP. Dilute Povidone-Iodine Irrigation: The Science of Molecular Iodine (I2) Kinetics and Its Antimicrobial Activity. J Am Acad Orthop Surg. 2025 Jan 15;33(2):65-73. doi: 10.5435/JAAOS-D-24-00471. Epub 2024 Oct 8.

    PubMed 39729104
  • Bigliardi PL, Alsagoff SAL, El-Kafrawi HY, Pyon JK, Wa CTC, Villa MA. Povidone iodine in wound healing: A review of current concepts and practices. Int J Surg. 2017 Aug;44:260-268. doi: 10.1016/j.ijsu.2017.06.073. Epub 2017 Jun 23.

    PubMed 28648795
  • Das T, Belenje A, Joseph J, Pandey S, Pandya D, Pandya R, Behera UC, Dave VP. Acute fungal post-cataract endophthalmitis in the endophthalmitis management study: EMS report 7. BMJ Open Ophthalmol. 2025 Aug 19;10(1):e002190. doi: 10.1136/bmjophth-2025-002190.

    PubMed 40835237
  • Das T, Pandey S, Joseph J, Sheth J, Belenje A, Behera UC, Kapoor A, Pandya R, Dave VP. Antibiotic susceptibility in Endophthalmitis Management Study and intravitreal antibiotic practice trend in India-EMS Report #5. Graefes Arch Clin Exp Ophthalmol. 2024 Jul;262(7):2163-2169. doi: 10.1007/s00417-024-06391-3. Epub 2024 Feb 6.

    PubMed 38319381
  • Dave VP, Belenje A, Dogra A, Das T; EMS working group. Application and validation of a novel inflammatory score in the clinical grading of infectious endophthalmitis: The endophthalmitis management study - Report 2. Indian J Ophthalmol. 2023 Feb;71(2):396-400. doi: 10.4103/ijo.IJO_1274_22.

    PubMed 36727325

Questions about this trial

What is this clinical trial studying?

A study testing Povidone-iodine intravitreal irrigation with povidone-iodine containing 0.0025% available iodine and BSS intravitreal irrigation solution in people with Endophthalmitis and Infectious Endophthalmitis, run by Beijing Tongren Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanyun Chen, M. D. (010-58268430, yanyun_chen@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infection control rate without silicone oil tamponade (time frame: Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07888205, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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