Phthisis BulbiNCT01312545
Comparison of Local Made and Imported Porous Polyethylene Orbital Implant for Enucleation in Thailand
A study testing 3DP and Medpor in people with Phthisis Bulbi, run by Mettapracharak Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phthisis Bulbi
- What is being tested?
- 3DP and Medpor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2011to 12 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has a history of prior enucleation or evisceration
- Cannot follow up for at least one year
- Has recent eye infection within 6 months
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Mettapracharak Eye Center, Mettapracharak (Wat Rai Khing) Hospital
Sam Phran, Changwat Nakhon Pathom, 73210
About this study
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
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?
Read the detailed description
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.
- Conditions
- Phthisis Bulbi
- Being tested
- 3DP, Medpor
- Keywords
- orbital implant, evisceration, economic, polyethylene, porous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DPDevice
intervention involving local made implant with different fabricating technique-3-dimensional printing (3DP) technique.
MedporDevice
commercial porous polyethylene
| Study group | Role | What they receive |
|---|---|---|
| local made implant (3DP) | Experimental | Enucleation and local made implant (3DP) insertion Receives: Device: 3DP |
| imported implant (Medpor) | Experimental | Enucleation and imported implant (Medpor) insertion Receives: Device: Medpor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure rate
Exposure was defined as the separation of tissue over the anterior surface of an implant.
Measured: From date of surgery until the date of first exposure, assessed up to 12 months
Secondary outcomes (1)
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.
Measured: From date of surgery until the date of first infection, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMar 2011
- Primary completion12 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phthisis BulbiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mettapracharak Hospital
- Sponsor type
- Other government
- Collaborators
- Thailand Research Fund, Prince of Songkla University, National Research Council of Thailand, National Science and Technology Development Agency, Thailand
- Responsible party
- Principal investigator, Dr. Sunisa Sintuwong, Mettapracharak Hospital
- Investigators
- Sunisa Sintuwong, MD,MPPM,MSc, Principal investigator, Mettapracharak (Wat Rai Khing) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312545
- Sponsor's protocol ID
- MEC1/2011
- Status last verified
- Dec 2020
- First submitted
- 7 Mar 2011
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01312545
- Acronym / sponsor ID
- MEC1/2011
- Conditions
- Phthisis Bulbi
- Keywords
- orbital implant, evisceration, economic, polyethylene, porous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Mettapracharak HospitalOther government
- Collaborators
- Thailand Research Fund, Prince of Songkla University, National Research Council of Thailand, National Science and Technology Development Agency, Thailand
- Study start
- Mar 2011
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local made implant (3DP) | Experimental | Device: 3DPEnucleation and local made implant (3DP) insertion |
| imported implant (Medpor) | Experimental | Device: MedporEnucleation and imported implant (Medpor) insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Has a history of prior enucleation or evisceration
- Cannot follow up for at least one year
- Has recent eye infection within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3DPintervention involving local made implant with different fabricating technique-3-dimensional printing (3DP) technique. | Device | local made implant (3DP) |
| Medporcommercial porous polyethylene | Device | imported implant (Medpor) |
Primary outcome
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.
1 secondary outcome
Infection rate
Time frame: From date of surgery until the date of first infection, assessed up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunisa Sintuwong, MD,MPPM,MSc principal investigator
Mettapracharak (Wat Rai Khing) Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3DP and Medpor in people with Phthisis Bulbi, run by Mettapracharak Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposure rate (time frame: From date of surgery until the date of first exposure, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.