Evidence map›Paper›PMID 25955359›Full record

Trial reportPloS one2015

Sutureless fixation of amniotic membrane for therapy of ocular surface disorders.

Ilya Kotomin, Monika Valtink, Kai Hofmann, Annika Frenzel, Henning Morawietz, Carsten Werner, Richard H W Funk, Katrin Engelmann

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02168790 (Interventional Study to Investigate the Safety of a Combination of Amniotic Membrane and a Holder Device), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.6field-weighted citation impact, top 18% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT02168790 early_phase1completednot on this map

Interventional Study to Investigate the Safety of a Combination of Amniotic Membrane and a Holder Device (AmnioClip) in the Therapy of Ocular Surface Disorders (Sutureless Amniotic Membrane Transplantation)

TypeinterventionalSponsorKlinikum Chemnitz gGmbHRan2011 to 2013Enrolled7ConditionsCorneal Ulcers, Corneal MeltingArmsAmniotic membrane ring
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 35 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Ilya KotominDepartment of Ophthalmology, Klinikum Chemnitz gGmbH, Chemnitz, Germany.
Monika ValtinkInstitute of Anatomy, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany.
Kai HofmannDeutsche Gesellschaft für Gewebetransplantation, DGFG, Hannover, Germany.
Annika FrenzelDivision of Vascular Endothelium and Microcirculation, Department of Medicine III, TU Dresden, Dresden, Germany.
Henning MorawietzDivision of Vascular Endothelium and Microcirculation, Department of Medicine III, TU Dresden, Dresden, Germany; CRTD / DFG-Center for Regenerative Therapies Dresden-Cluster of Excellence, Dresden, Germany.
Carsten WernerCRTD / DFG-Center for Regenerative Therapies Dresden-Cluster of Excellence, Dresden, Germany; Leibniz-Institut für Polymerforschung Dresden e.V., Dresden, Germany.
Richard H W FunkInstitute of Anatomy, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany; CRTD / DFG-Center for Regenerative Therapies Dresden-Cluster of Excellence, Dresden, Germany.
Katrin EngelmannDepartment of Ophthalmology, Klinikum Chemnitz gGmbH, Chemnitz, Germany; Deutsche Gesellschaft für Gewebetransplantation, DGFG, Hannover, Germany; CRTD / DFG-Center for Regenerative Therapies Dresden-Cluster of Excellence, Dresden, Germany.
TU Dresden · DEKlinikum Chemnitz · DEDeutsche Gesellschaft für Information und Wissen · DELeibniz Institute of Polymer Research · DEUniversity Hospital Carl Gustav Carus · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Amniotic membrane is applied to the diseased ocular surface to stimulate wound healing and tissue repair, because it releases supportive growth factors and cytokines. These effects fade within about a week after application, necessitating repeated application. Generally, amniotic membrane is fixed with sutures to the ocular surface, but surgical intervention at the inflamed or diseased site can be detrimental. Therefore, we have developed a system for the mounting of amniotic membrane between two rings for application to a diseased ocular surface without surgical intervention (sutureless amniotic membrane transplantation). With this system, AmnioClip, amniotic membrane can be applied like a large contact lens. First prototypes were tested in an experiment on oneself for wearing comfort. The final system was tested on 7 patients in a pilot study. A possible influence of the ring system on the biological effects of amniotic membrane was analyzed by histochemistry and by analyzing the expression of vascular endothelial growth factor-A (VEGF-A), hepatocyte growth factor (HGF), fibroblast growth factor 2 (FGF 2) and pigment epithelium-derived factor (PEDF) from amniotic membranes before and after therapeutic application. The final product, AmnioClip, showed good tolerance and did not impair the biological effects of amniotic membrane. VEGF-A and PEDF mRNA was expressed in amniotic membrane after storage and mounting before transplantation, but was undetectable after a 7-day application period. Consequently, transplantation of amniotic membranes with AmnioClip provides a sutureless and hence improved therapeutic strategy for corneal surface disorders.Trial Registration:ClinicalTrials.gov NCT02168790

Indexed as

Biological DressingsAdultAgedAged, 80 and overAmnionBiomarkersCorneaCorneal DiseasesEpithelium, CornealEquipment DesignEye ProteinsFemaleFibroblast Growth Factor 2Gene ExpressionHepatocyte Growth FactorHumansBiomarkersEye ProteinsFibroblast Growth Factor 2Hepatocyte Growth FactorHGF protein, humanNerve Growth FactorsPigment Epithelium-Derived FactorSerpinsVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID25955359
PMCPMC4425509
OpenAlexW339863725

What OpenQuestion holds

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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.