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Comparison between local-made and imported porous polyethylene orbital implant:a randomized controlled equivalence trial and multicenter study

引用

International Journal of Ophthalmology(English edition) 2024年第10期17卷 1857-1863页

作者： Sunisa Sintuwong Kanjana Leelapatranurak Orapan Aryasit Passorn Preechawai Mingkwan Lumyongsatien Ornvenus Nimitwongsakul Jugchawin Kanokkantapong Unnkade Bhaktikamala Yongyot Tuachob Jirapol Bhuntuveh Pennung Thongtong Waraporn Suvannapruk Jintamai Suwanprateeb Department of Ophthalmology Mettapracharak(Wat Rai Khing)HospitalNakhon Pathom 73210Thailand Department of Ophthalmology Faculty of MedicinePrince of Songkla UniversitySongkhla 90110Thailand National Metal and Materials Technology Center(MTEC) National Science and Technology Development Agency(NSTDA)Pathum Thani 12120Thailand Thammasat University Center of Excellence in Computational Mechanics and Medical Engineering Thammasat UniversityPathum Thani 12120Thailand

AIM:To compare the exposure rate,infection rate,percentage of enhancement,and success rate between Medpor and the three-dimensional printed polyethylene(3DP-PE)orbital implant in a preliminary ***:This prospective,randomized,equivalence,controlled trial was conducted at two *** equivalent margin was±10%.The sample size for the equivalence trial was 174 participants per *** who were eligible for enucleations received either Medpor or 3DP-PE implants based on a randomized block of *** surgeries were performed by five oculoplastic *** assessor and patients were *** magnetic resonance imaging(MRI)of the orbit was performed at least 6mo after operation and the fibrovascular ingrowth was analyzed using the Image J ***-up continued at least 1y after *** intention to treat and per protocol approaches were ***:Totally 128 patients met the criteria in the *** Medpor and 553DP-PE cases completed the *** most common cause of blindness was *** mean follow-up times of Medpor and 3DP-PE were 33 and 40mo *** exposure rate was not statistically significant between two groups(6.0%and 7.3%),Penucleation in the ***,we cannot conclude that they are equivalent in terms of the exposure rate and success rate because the 95%CI is wider than±10%.The infection rate is equivalent in both groups.

关键词： orbital implants eyeball enucleation polyethylene blindness eye injuries orbit

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