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| ID | Type | Description | Link |
|---|---|---|---|
| 2010/17350-6 | Other Grant/Funding Number | Fundação de Amparo à Pesquisa do Estado de São Paulo |
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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-iodine | Experimental | 1 drop of povidone-iodine 5% will be instilled at time zero, 20-minute and 28-minute study period. |
|
| Povidone-iodine and Saline Solution | Active Comparator | 1 drop of saline solution 0.9% will be instilled at time zero and 20-minute. At 28-minute will be instilled 1 drop of Povidone-iodine 5%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-iodine | Other | Povidone iodine 5% drop will be instilled into conjunctival sac. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of negative cultures after treatment in both groups | 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). | At 30-minute study period, a conjunctival sac swab will be obtained |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in corneal thickness change between groups. | Corneal paquimetry will be performed before and after procedure using OcuScan Alcon RXP (Alcon, Fortworth, Texas). | At 35-minute study period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Jorge, MD, PhD | University of Sao Paulo | Principal Investigator |
| Leticia F Barroso, MD | Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinics Hospital of Ribeirão Preto | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
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| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D009877 | Endophthalmitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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| Saline Solution | Other | 1 drop of saline solution 0.9% will be instilled into conjunctival sac. |
|
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |