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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mettapracharak Hospital
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01312545
First received: March 7, 2011
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Phthisis Bulbi
Device: 3DP
Device: Medpor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mettapracharak Hospital:

Primary Outcome Measures:
  • Exposure rate [ Time Frame: From date of surgery until the date of first exposure, assessed up to 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 130
Study Start Date: March 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • Need additional surgery eg. fornix reconstruction, etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312545

Contacts
Contact: Sunisa Sintuwong, MD 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, M.D.    66 34 225 818 ext 7168    drsunisa@gmail.com   
Contact: Kanjana Leelapatranurak, MD    66 34 225 818    kanjana_nue@yahoo.com   
Principal Investigator: Sunisa Sintuwong, MD         
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 Mettapracharak (Wat Raikhing) Hospital
  More Information

No publications provided

Responsible Party: Dr. Sunisa Sintuwong, Dr., Mettapracharak Hospital
ClinicalTrials.gov Identifier: NCT01312545     History of Changes
Other Study ID Numbers: MEC1/2011
Study First Received: March 7, 2011
Last Updated: May 13, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Mettapracharak Hospital:
orbital implant
evisceration
economic
polyethylene
porous

Additional relevant MeSH terms:
Tuberculosis, Pulmonary
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 01, 2014