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

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?

Study Overview

• Status: Completed
• Conditions: Phthisis Bulbi
• Intervention / Treatment: Device: 3DP; Device: Medpor

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Nakhon Pathom
    • Sam Phran, Nakhon Pathom, Thailand, 73210
      • Mettapracharak Eye Center, Mettapracharak (Wat Rai Khing) Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mettapracharak Hospital
• Collaborators: Prince of Songkla University; National Research Council of Thailand; Thailand Research Fund; National Science and Technology Development Agency, Thailand
• Investigators: Principal Investigator: Sunisa Sintuwong, MD,MPPM,MSc, Mettapracharak (Wat Rai Khing) Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): December 12, 2020
• Study Completion (ACTUAL): December 12, 2020

Study Registration Dates

• First Submitted: March 7, 2011
• First Submitted That Met QC Criteria: March 9, 2011
• First Posted (ESTIMATE): March 10, 2011

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: economic; orbital implant; evisceration; polyethylene; porous
• Other Study ID Numbers: MEC1/2011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO