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

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

SUBMITTER: Kotomin I

PROVIDER: S-EPMC4425509 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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

Kotomin Ilya I Valtink Monika M Hofmann Kai K Frenzel Annika A Morawietz Henning H Werner Carsten C Funk Richard H W RH Engelmann Katrin K

PloS one 20150508 5

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 tw ...[more]

PMID: 25955359

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Project description:BackgroundOcular surface burns can be caused by chemicals (alkalis and acids) or by direct heat. Amniotic membrane transplantation (AMT) performed in the acute phase (day 0 to day 7) of an ocular surface burn is reported to relieve pain, accelerate healing and reduce scarring and blood vessel formation. The surgery involves applying a patch of amniotic membrane (AM) over the entire ocular surface up to the eyelid margins.ObjectivesTo assess the effects of AMT on the eyes of people having suffered acute ocular surface burns.Search methodsWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 6), MEDLINE (January 1946 to June 2012), EMBASE (January 1980 to June 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to June 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 11 June 2012.Selection criteriaWe included randomised trials of medical therapy and AMT applied in the first seven days after an ocular surface burn compared to medical therapy alone.Data collection and analysisTwo authors independently assessed the risk of bias of included studies and extracted relevant data. We contacted trial investigators for missing information. We summarised data using risk ratios (RRs) and mean differences (MDs) as appropriate.Main resultsWe included one RCT of 100 participants with ocular burns that were randomised to treatment with AMT and medical therapy or medical therapy alone. A subset of patients (n = 68) who were treated within the first seven days of the injury met the inclusion criteria and were included in the analysis. The remaining 32 eyes were excluded. The included subset consisted of 36 moderate (Dua classification II-III) and 32 severe (Dua classification IV-VI) ocular burns from alkali, acid and thermal injuries. In the moderate category, 13/20 control eyes and 14/16 treatment eyes had complete epithelialisation by 21 days. The RR of failure of epithelialisation by day 21 was 0.18 in the treatment group (95% confidence interval (CI) 0.02 to 1.31; P = 0.09). Mean LogMAR final visual acuities were 0.06 (standard deviation (SD) 0.10) in the treatment group and 0.38 (SD 0.52) in the control group, representing a MD of -0.32 (95% CI -0.05 to -0.59). In the severe category, 1/17 treatment and 1/15 control eyes were epithelialised by day 21. The RR of failure of epithelialisation in the treatment group was 1.01 (95% CI 0.84 to 1.21; P = 0.93). Final visual acuity was 1.77 (SD 1.31) in the treated eyes and 1.64 (SD 1.48) in the control group (MD 0.13; 95% CI -0.88 to 1.14). The risks of performance and detection biases were high, because treating personnel and outcome assessors could not be masked to treatment. There was also a high risk of bias in the visual outcomes of the moderate category, since mean visual acuity was significantly worse at presentation in the control eyes. This reduced confidence in the study findings.Authors' conclusionsConclusive evidence supporting the treatment of acute ocular surface burns with AMT is lacking. Heterogeneity of disease presentation, variations in treatment, undefined criteria for treatment success and failure, and non-uniform outcome measures are some of the factors complicating the search for clear evidence regarding this treatment.

Project description:BackgroundCorneal disease is the second most common cause of blindness in China. Clinically, treatment options for corneal diseases with limbal stem cell deficiency (LSCD) are limited due to a shortage of organ donors and inevitable immune rejection. This study aims to determine the efficacy of reconstructing the ocular surface using autologous cultivated adipose tissue-derived stem cells (ADSCs) and to develop a new clinical treatment for patients with LSCD.MethodsA rabbit LSCD model was first established. Two weeks later, the animals were divided into three groups, including the sham group, the amniotic membrane transplantation group, and the ADSC combined with amniotic membrane transplantation group, and underwent surgery. The efficacy of reconstructing the ocular surface using ADSCs was evaluated using immunofluorescent staining, confocal microscopy (CM) observation, H&E staining, immunohistochemical staining, and scanning transmission electron microscopy observation one, two and four weeks after surgery.ResultsEvaluations of immunofluorescent staining of the cornea pre- and post-surgery yielded significantly lower scores for the corneas in the ADSCs transplantation group than for those in the sham group (F=-7, P=0.002, <0.05) and the amniotic membrane transplantation group (F=-4.67, P=0.018, <0.05) two weeks after surgery. Four weeks after surgery, the corneas of the ADSC combined with amniotic membrane transplantation group were scored significantly lower than those in the sham group (F=-8, P=0.007, <0.05) and the amniotic membrane transplantation group (F=-5.33, P=0.046, <0.05). The data suggest that the use of ADSCs to treat LSCD showed greater efficacy than the other treatment methods. The growth of ADSCs on the corneal surface was examined using confocal and electron microscopes. K3/K12 expression in the corneal epithelium, which was reconstructed by ADSCs, was negative, as shown by immunohistochemical staining.ConclusionsOcular surface reconstruction can be improved by using ADSCs as seed cells and the amniotic membrane as a carrier, thus providing a new therapeutic strategy for patients with LSCD.

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

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

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