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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001179-35 | EudraCT Number |
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Not the expected 2/3 but only 1/3 of conjunctiva samples got bacterial growth. Lack of resources to keep the study going with more participants and over a considerably longer time than anticipated.
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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Topical povidone-iodine (PI) is widely used as ocular antiseptic before and after surgery. The standard dose of 5% PI is however, associated with ocular irritation. We therefore want to test if a lower concentration of PI can be similarly efficacious in reducing bacterial growth while reducing ocular irritation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-Iodine 0.3 % | Experimental | A tampon is soaked in diluted PI 0.3% and placed on the inside of the lower eyelid of one eye, where it will release iodine molecules for 20 minutes before being removed. |
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| Povidone-Iodine 5 % | Active Comparator | Eye drops of 5% PI is the standard disinfection before eye surgery. The drops will be dripped in one eye and allowed to work for 2 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine 0.3% | Drug | Low concentration iodine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival bacterial culture | Change in colony-forming units (CFU) per milliliter (ml) | 1 hour. Bacterial sample is taken before and immediately after disinfection |
| Measure | Description | Time Frame |
|---|---|---|
| Patient pain score | Verbal numeric rating scale, from 0 to 10. | During disinfection and after 1 hour when the anesthetic no longer is effective |
| Ocular staining score (OSS) | Modified OSS using fluorescein dye |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorunn Helbostad, MD PhD | Norwegian University of Science and Technology | Study Director |
| Marit Fagerli, MD | Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital | Trondheim | Norway |
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| ID | Term |
|---|---|
| D015817 | Eye Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005128 | Eye Diseases |
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Both eyes of the participants are tested; one eye randomised to receive the intervention and the second eye to receive the standard disinfection.
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| Povidone-Iodine 5% |
| Drug |
Standard concentration iodine |
|
| 1 hour after disinfection |