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| Name | Class |
|---|---|
| Thailand Research Fund | OTHER |
| Prince of Songkla University | OTHER |
| National Research Council of Thailand | OTHER_GOV |
| National Science and Technology Development Agency, Thailand |
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This study wants to compare between two types of implants in enucleation. Both of them are made from porous polyethylene but have different fabricating techniques. The investigators chose an exposure rate as a main outcome because the investigators think it is the most important outcome for the surgeons. The study hypothesis is: Is the exposure rate of a local-made polyethylene orbital implant the same as an imported one?
Sample size assessment
Data management
Plan for missing data
Statistical analysis
- Intention to treat and per protocol model would be used to see the difference between two types of implants in this project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local made implant (3DP) | Experimental | Enucleation and local made implant (3DP) insertion |
|
| imported implant (Medpor) | Experimental | Enucleation and imported implant (Medpor) insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3DP | Device | intervention involving local made implant with different fabricating technique-3-dimensional printing (3DP) technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exposure rate | Exposure was defined as the separation of tissue over the anterior surface of an implant. | From date of surgery until the date of first exposure, assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Infection rate | Infection was defined as the presence of pus or abscess at or around an implant. It can be diagnosed clinically or confirmed by the histopathology report after explantation. | From date of surgery until the date of first infection, assessed up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunisa Sintuwong, MD,MPPM,MSc | Mettapracharak (Wat Rai Khing) Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mettapracharak Eye Center, Mettapracharak (Wat Rai Khing) Hospital | Sam Phran | Changwat Nakhon Pathom | 73210 | Thailand |
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| OTHER_GOV |
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| Medpor | Device | commercial porous polyethylene |
|