Comparison of Local Made and Imported Porous Polyethylene Orbital Implant for Enucleation in Thailand
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| ClinicalTrials.gov Identifier: NCT01312545 |
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Recruitment Status :
Recruiting
First Posted : March 10, 2011
Last Update Posted : January 4, 2018
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Sponsor:
Mettapracharak Hospital
Collaborators:
Thailand Research Fund
Prince of Songkla University
National Research Council of Thailand
National Science and Technology Development Agency, Thailand
Information provided by (Responsible Party):
Dr. Sunisa Sintuwong, Mettapracharak Hospital
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Brief Summary:
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?
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Phthisis Bulbi | Device: 3DP Device: Medpor | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | March 2011 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2020 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Polyethylene
| Arm | Intervention/treatment |
|---|---|
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Experimental: local made implant (3DP)
Enucleation and local made implant (3DP) insertion
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Device: 3DP
intervention involving local made implant with different fabricating technique-3-dimensional printing (3DP) technique. |
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Experimental: imported implant (Medpor)
Enucleation and imported implant (Medpor) insertion
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Device: Medpor
commercial porous polyethylene |
Primary Outcome Measures :
- Exposure rate [ Time Frame: From date of surgery until the date of first exposure, assessed up to 12 months ]Exposure was defined as the separation of tissue over the anterior surface of an implant.
Secondary Outcome Measures :
- Infection rate [ Time Frame: From date of surgery until the date of first infection, assessed up to 12 months ]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.
- Motility [ Time Frame: 2,3,6,9,12 months post surgery ]Motility was defined as the distance in millimeters the patients can move their eyes in abduction, adduction, supraduction and infraduction. The rulers will be attached to the slit lamp in horizontal and vertical axis.The observer then take a photo of patients in 4 directions, with and without prosthesis. Two independent observers will measure motilities from the photographs. If the difference from two independent observers is more than 2 standard deviation, the measurement process will be started again.
- Gadolinium enhancement [ Time Frame: 6, 12 months post surgery ]Gadolinium uptake from MRI orbit represents implant vascularization. They will be taken in axial, coronal and sagittal plane with standard protocol MRI study. In T1-weighted post contrast image, an equatorial image will be identified. The equatorial image was defined as the image at the level of implant size divided by two, measured from the anterior surface. Two independent observer will mark between contrast and non-contrast area. Then area of enhancement was calculated by subtracting non-enhancement area from total equatorial surface area.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312545
Contacts
| Contact: Sunisa Sintuwong, MD,MPPM,MSc | 66 34 225818 ext 7168 | drsunisa@gmail.com |
Locations
| Thailand | |
| Mettapracharak Eye Center, Mettapracharak (Wat Raikhing) Hospital | Recruiting |
| Amphoe Sam Phran, Nakhon Pathom, Thailand, 73210 | |
| Contact: Sunisa Sintuwong, MD,MPPM,MSc 66 34 225 818 ext 7168 drsunisa@gmail.com | |
| Contact: Mingkwan Lumyongsatien, MD. 66 34 225 818 mingkwanlum@gmail.com | |
| Principal Investigator: Sunisa Sintuwong, MD,MPPM,MSc | |
Sponsors and Collaborators
Mettapracharak Hospital
Thailand Research Fund
Prince of Songkla University
National Research Council of Thailand
National Science and Technology Development Agency, Thailand
Investigators
| Principal Investigator: | Sunisa Sintuwong, MD,MPPM,MSc | Mettapracharak (Wat Raikhing) Hospital |
| Responsible Party: | Dr. Sunisa Sintuwong, Dr., Mettapracharak Hospital |
| ClinicalTrials.gov Identifier: | NCT01312545 History of Changes |
| Other Study ID Numbers: |
MEC1/2011 |
| First Posted: | March 10, 2011 Key Record Dates |
| Last Update Posted: | January 4, 2018 |
| Last Verified: | January 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Dr. Sunisa Sintuwong, Mettapracharak Hospital:
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orbital implant evisceration economic polyethylene porous |