An interventional study of Povidone-iodine intravitreal irrigation with povidone-iodine containing 0.0025% available iodine and BSS intravitreal irrigation solution in Endophthalmitis and Infectious Endophthalmitis, sponsored by Beijing Tongren Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Endophthalmitis; 9 are open to participants now.
This study's planned enrollment of 38 is below the median of 112 across 33 interventional studies indexed under Endophthalmitis.
Browse Endophthalmitis studies →Beijing Tongren Hospital is the lead sponsor of 163 studies on the registry; 53 are open to participants now.
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Exclusion Criteria:
Standard 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.
Procedure: Povidone-iodine intravitreal irrigation with povidone-iodine containing 0.0025% available iodine
Standard 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.
Procedure: BSS intravitreal irrigation solution
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.
After vitrectomy, balanced salt solution (BSS) without povidone-iodine was used for intravitreal irrigation.
Infection control rate without silicone oil tamponade
The infection control rate of the patient without silicone oil tamponade 14 days after the operation
Time frame: Day 14
Best-Corrected Visual Acuity (BCVA) Change
Change in LogMAR BCVA from baseline to post-op follow-up points.
Time frame: Baseline, Day 7, Month 1, Month 3, and Month 6
No study locations are listed for this record.
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Plan to share: No
Start is estimated for Oct 2026; primary completion for Mar 2028, 17 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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