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

Phthisis Bulbi Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312545
• Other study ID #: MEC1/2011
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: December 12, 2020

Study information

• Verified date: December 2020
• Source: Mettapracharak Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The study hypothesis is: Is the exposure rate of a local-made polyethylene orbital implant the same as an imported one?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Phthisis Bulbi

Intervention

Device:
• 3DP
intervention involving local made implant with different fabricating technique-3-dimensional printing (3DP) technique.
• Medpor
commercial porous polyethylene

Locations

Country	Name	City	State
Thailand	Mettapracharak Eye Center, Mettapracharak (Wat Rai Khing) Hospital	Sam Phran	Nakhon Pathom

Sponsors (5)

Lead Sponsor	Collaborator
Mettapracharak Hospital	National Research Council of Thailand, National Science and Technology Development Agency, Thailand, Prince of Songkla University, Thailand Research Fund

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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