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NCT Number: NCT01312545

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

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?

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Key information

Conditions

Phthisis Bulbi

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mettapracharak Eye Center, Mettapracharak (Wat Rai Khing) Hospital

Sam Phran, Changwat Nakhon Pathom, 73210, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3DP

Device

intervention involving local made implant with different fabricating technique-3-dimensional printing (3DP) technique.

Medpor

Device

commercial porous polyethylene

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mettapracharak Hospital

Other Gov

Collaborators

  • National Research Council of Thailand
  • National Science and Technology Development Agency, Thailand
  • Prince of Songkla University
  • Thailand Research Fund

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2011
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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