Clinical trial NCT01312545: Comparison of Local Made and Imported Porous Polyethylene Orbital Implant for Enucleation in Thailand
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phthisis Bulbi
Keywords: orbital implant
evisceration
economic
polyethylene
porous
Lead sponsor: Mettapracharak Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Thailand Research Fund
name: Prince of Songkla University
name: National Research Council of Thailand
name: National Science and Technology Development Agency, Thailand
First posted: 2011-03-10
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility 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

Primary outcomes:
measure: Exposure rate
timeFrame: From date of surgery until the date of first exposure, assessed up to 12 months
Secondary outcomes:
measure: Infection rate
timeFrame: From date of surgery until the date of first infection, assessed up to 12 months
Other outcomes:
Locations:
city: Sam Phran
country: Thailand
facility: Mettapracharak Eye Center, Mettapracharak (Wat Rai Khing) Hospital
state: Nakhon Pathom
Study officials:
affiliation: Mettapracharak (Wat Rai Khing) Hospital
name: Sunisa Sintuwong, MD,MPPM,MSc
role: PRINCIPAL_INVESTIGATOR
References: