ArticleInternational journal of ophthalmology2024
Comparison between local-made and imported porous polyethylene orbital implant: a randomized controlled equivalence trial and multicenter study.
Article in International journal of ophthalmology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo 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 report.
methodsThis prospective, randomized, equivalence, controlled trial was conducted at two institutes. The equivalent margin was ±10%. The sample size for the equivalence trial was 174 participants per group. Patients who were eligible for enucleations received either Medpor or 3DP-PE implants based on a randomized block of six. The surgeries were performed by five oculoplastic surgeons. The assessor and patients were masked. The magnetic resonance imaging (MRI) of the orbit was performed at least 6mo after operation and the fibrovascular ingrowth was analyzed using the Image J software. Follow-up continued at least 1y after surgery. The intention to treat and per protocol approaches were used.
resultsTotally 128 patients met the criteria in the report. Fifty Medpor and 55 3DP-PE cases completed the trial. The most common cause of blindness was trauma. The mean follow-up times of Medpor and 3DP-PE were 33 and 40mo respectively. The exposure rate was not statistically significant between two groups (6.0% and 7.3%),
conclusionThere is no statistically significant difference in exposure rate and success rate between Medpor and 3DP-PE in enucleation in the report. However, 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.