Eye Infections
Conditions
Keywords
Povidone-Iodine, Ophthalmic Solutions, Endophthalmitis, Preoperative procedures
Brief summary
The present study intends to assess the efficacy of 3 drops of 5% povidone-iodine (PVPI) eyedrops in reducing the bacterial flora in a conjunctival sac fundus compared to the standard procedure consisting of the application of 1 PVPI eyedrop 2 min before any intraocular surgical procedure.
Detailed description
Studies have demonstrated that the external bacterial flora of the patients in most cases is the actual source of infection. The objective of antisepsis is to eliminate or significantly reduce the number of microorganisms in the surgical field at the time of surgery. The eyelids and the conjunctiva are considered to be quite common sources of bacteria that can lead to endophthalmitis. Thus, it is believed that by reducing the number and growth of bacteria on the ocular surface and adnexa before surgery, the risk of postoperative infection would be lower. Povidone-iodine 5% eye drops has been used in preoperative cataract surgery to prevent endophthalmitis and is the standard prophylactic action in preventing postoperative endophthalmitis being widely compared with other antibiotic eye drops and their associations. The standard procedure of prophylaxis of postoperative endophthalmitis corresponds to applying a single drop of povidone-iodine 2min before any intraocular surgical procedure. However, few studies have assessed the effectiveness of povidone-iodine 5% eye drops using different dosing regimens to achieve the best bactericidal effect. The aim of this study is to investigate different dosages with respect to the use of povidone-iodine drops to optimize the effectiveness of the agent, ensuring the best exogenous endophthalmitis prophylaxis.
Interventions
OTHERPovidone-iodine
Povidone iodine 5% drop will be instilled into conjunctival sac.
OTHERSaline Solution
1 drop of saline solution 0.9% will be instilled into conjunctival sac.
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* No systemic or ocular infection; * Absence of auto-imune disease or immunosuppressive therapy; * No use of systemic or topic antibiotics in the last 30 days; * No previous ocular surgery or trauma in the study eye in the last 30 days; * No history of allergy to povidone iodine; * Signed informed consent.
Exclusion criteria
* Presence of blepharitis, ectropion, entropion, trichiasis or distichiasis; * Diabetes Mellitus; * Any systemic condition that, at the discretion of the investigators, would facilitate or contribute to infection, such as influenza; * Inability to understand and sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of negative cultures after treatment in both groups | At 30-minute study period, a conjunctival sac swab will be obtained | Conjunctival swab will be obtained five minutes before and 30 minutes after the first povidone iodine drop will be instilled into the conjunctival sac of study eye. Conjunctival swabs were incubated aerobically in enriched Thioglycolate liquid medium (meat broth) and in three solid culture media (Agar Chocolate, Trypticase Soy Agar with 5% sheep blood, and Agar Sabouraud). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in corneal thickness change between groups. | At 35-minute study period. | Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas). |
Countries
Brazil
Outcome results
None listed