Comparison of Local Made and Imported Porous Polyethylene Orbital Implant for Enucleation in Thailand

Study Overview
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Brief Summary
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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?

Detailed Description
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Sample size assessment The sample size was calculated by using an equivalence formula. From a literature and our own experiences, the success rate for Medpor and 3DP were 92% and 94% respectively, the difference (D) of the success rate between two groups was 10% and assuming a 15% of drop out rate. Then allocation sequence was generated by a computerized program, using block of six with varying block size. Data management All definition of data, recruiting techniques, data collection techniques and data management flow were mentioned in the SOP. After double entry technique, each case record form from each site will be sent via DataFax system to the data center at Center of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Thailand. Then data will be validated, analyzed and reported by staff at BIOPHICS. Plan for missing data by adding a drop out rate to the sample size calculation. by choosing the right patients. Actually, Thai patients have good co-operation especially in surgical research. Statistical analysis - Intention to treat and per protocol model would be used to see the difference between two types of implants in this project.

Official Title
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Comparison of Exposure Rate Between Local Made and Imported Porous Polyethylene Orbital Implant for Enucleation in Thailand: A Randomized, Equivalence Controlled Trial and Multicenter Study

Conditions
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Phthisis Bulbi

Intervention / Treatment
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* Device: 3DP
* Device: Medpor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of phthisis bulbi, painful blindness, intraocular tumor without metastasis and severe ruptured eyeball Must speak and understand Thai language well Must have good consciousness Exclusion Criteria: Has a history of prior enucleation or evisceration Cannot follow up for at least one year Has recent eye infection within 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: local made implant (3DP)<br>Enucleation and local made implant (3DP) insertion | Device: 3DP<br>* intervention involving local made implant with different fabricating technique-3-dimensional printing (3DP) technique.<br>|
| Experimental: imported implant (Medpor)<br>Enucleation and imported implant (Medpor) insertion | Device: Medpor<br>* commercial porous polyethylene<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orbital implant, evisceration, economic, polyethylene, porous