NCT01312545

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2020

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

9.8 years

First QC Date

March 7, 2011

Last Update Submit

December 11, 2020

Conditions

Phthisis Bulbi

Keywords

orbital implanteviscerationeconomicpolyethyleneporous

Outcome Measures

Primary Outcomes (1)

  • Exposure rate

    Exposure was defined as the separation of tissue over the anterior surface of an implant.

    From date of surgery until the date of first exposure, assessed up to 12 months

Secondary Outcomes (1)

  • Infection rate

    From date of surgery until the date of first infection, assessed up to 12 months

Study Arms (2)

local made implant (3DP)

EXPERIMENTAL

Enucleation and local made implant (3DP) insertion

Device: 3DP

imported implant (Medpor)

EXPERIMENTAL

Enucleation and imported implant (Medpor) insertion

Device: Medpor

Interventions

3DPDEVICE

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

local made implant (3DP)
MedporDEVICE

commercial porous polyethylene

imported implant (Medpor)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Has a history of prior enucleation or evisceration
  • Cannot follow up for at least one year
  • Has recent eye infection within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mettapracharak Eye Center, Mettapracharak (Wat Rai Khing) Hospital

Sam Phran, Changwat Nakhon Pathom, 73210, Thailand

Location

Study Officials

  • Sunisa Sintuwong, MD,MPPM,MSc

    Mettapracharak (Wat Rai Khing) Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 10, 2011

Study Start

March 1, 2011

Primary Completion

December 12, 2020

Study Completion

December 12, 2020

Last Updated

December 14, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)