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

NCT ID: NCT01312545

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2020-12-12

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Phthisis Bulbi

Keywords

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orbital implant evisceration economic polyethylene porous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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local made implant (3DP)

Enucleation and local made implant (3DP) insertion

Group Type EXPERIMENTAL

3DP

Intervention Type DEVICE

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

imported implant (Medpor)

Enucleation and imported implant (Medpor) insertion

Group Type EXPERIMENTAL

Medpor

Intervention Type DEVICE

commercial porous polyethylene

Interventions

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3DP

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

Intervention Type DEVICE

Medpor

commercial porous polyethylene

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thailand Research Fund

OTHER

Sponsor Role collaborator

Prince of Songkla University

OTHER

Sponsor Role collaborator

National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

National Science and Technology Development Agency, Thailand

OTHER_GOV

Sponsor Role collaborator

Mettapracharak Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Sunisa Sintuwong

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunisa Sintuwong, MD,MPPM,MSc

Role: PRINCIPAL_INVESTIGATOR

Mettapracharak (Wat Rai Khing) Hospital

Locations

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Mettapracharak Eye Center, Mettapracharak (Wat Rai Khing) Hospital

Sam Phran, Changwat Nakhon Pathom, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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MEC1/2011

Identifier Type: -

Identifier Source: org_study_id