Clinical Research Directory

Vitrectomy Combined With Povidone-Iodine Vitreous Irrigation for Infectious Endophthalmitis

Sponsor: Beijing Tongren Hospital

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. 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.

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

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