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

NCT01312545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-12-14

No results posted yet for this study

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?

Conditions

  • Phthisis Bulbi

Interventions

DEVICE

3DP

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

DEVICE

Medpor

commercial porous polyethylene

Sponsors & Collaborators

  • Thailand Research Fund

    collaborator OTHER

  • Prince of Songkla University

    collaborator OTHER

  • National Research Council of Thailand

    collaborator OTHER_GOV

  • National Science and Technology Development Agency, Thailand

    collaborator OTHER_GOV

  • Mettapracharak Hospital

    lead OTHER_GOV

Principal Investigators

  • Sunisa Sintuwong, MD,MPPM,MSc · Mettapracharak (Wat Rai Khing) Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2020-12-12
Completion
2020-12-12

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01312545 on ClinicalTrials.gov