We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01312545
Recruitment Status : Recruiting
First Posted : March 10, 2011
Last Update Posted : January 4, 2018
Information provided by (Responsible Party):

Study Description
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?

Condition or disease Intervention/treatment Phase
Phthisis Bulbi Device: 3DP Device: Medpor Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Infection rate [ Time Frame: From date of surgery until the date of first infection, assessed up to 12 months ]
    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.

  2. Motility [ Time Frame: 2,3,6,9,12 months post surgery ]
    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.

  3. Gadolinium enhancement [ Time Frame: 6, 12 months post surgery ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312545

Contact: Sunisa Sintuwong, MD,MPPM,MSc 66 34 225818 ext 7168 drsunisa@gmail.com

Mettapracharak Eye Center, Mettapracharak (Wat Raikhing) Hospital Recruiting
Amphoe Sam Phran, Nakhon Pathom, Thailand, 73210
Contact: Sunisa Sintuwong, MD,MPPM,MSc    66 34 225 818 ext 7168    drsunisa@gmail.com   
Contact: Mingkwan Lumyongsatien, MD.    66 34 225 818    mingkwanlum@gmail.com   
Principal Investigator: Sunisa Sintuwong, MD,MPPM,MSc         
Sponsors and Collaborators
Mettapracharak Hospital
Thailand Research Fund
Prince of Songkla University
National Research Council of Thailand
National Science and Technology Development Agency, Thailand
Principal Investigator: Sunisa Sintuwong, MD,MPPM,MSc Mettapracharak (Wat Raikhing) Hospital
More Information

Responsible Party: Dr. Sunisa Sintuwong, Dr., Mettapracharak Hospital
ClinicalTrials.gov Identifier: NCT01312545     History of Changes
Other Study ID Numbers: MEC1/2011
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Sunisa Sintuwong, Mettapracharak Hospital:
orbital implant