Dataset Information

Amniotic membrane transplantation for ocular disease: a review of the first 233 cases from the UK user group.

ABSTRACT:

Background

Amniotic membrane transplantation (AMT), as a new tool in the armamentarium of therapies available for ocular surface problems, became widely available in the UK in 1998. This study evaluates the indications for treatment, the surgical procedures used, and the results of a subset of the first AMT cases carried out by the group using this nationally available supply. This user group model provides data which is different from that obtained from uncontrolled case series, or clinical trials, and may be more representative of the outcomes that can be expected when a procedure becomes widely available.

Methods

The first 233 AMTs, performed by the UK user group, were evaluated by audit and outcomes were assessed at 3 months.

Results

Of the 233 transplants, there were 126 (54.1%) valid outcome returns: the outcome for persistent epithelial defects was a healed and stable surface in 11/35 (31.4%, 95% CI 16.9 to 49.3); for chemical/thermal injuries, a healed uninflamed eye with clear cornea in 5/18 (27.8%, 95% CI 9.7 to 53.4); for bullous keratopathy a pain-free, stable surface without bullae in 4/18 (22.2%, 95% CI 6.4 to 47.6); for ocular surface reconstruction, an epithelialised uninflamed conjunctiva without scarring in 12/23 (52.2%, 95% CI 30.6 to 73.2); and for limbal stem cell deficiency, a corneal phenotype in 4/7 (57.1%). The operative technique least associated with failure was use of a bandage contact lens at the end of the procedure (OR 0.19, 95% CI 0.06 to 0.59, p = 0.004). Previous treatment with topical steroids was significantly associated with failure (OR 5.70, 95% CI 1.77 to 18.43, p = 0.004).

Conclusion

Although the outcome criteria used in this study were stringent, and the follow-up duration was short, the results of AMT by this user group were generally less favourable than those of previously reported case series. Controlled clinical trials would improve the quality of evidence for use of amniotic membrane in ocular disease.

SUBMITTER: Saw VP

PROVIDER: S-EPMC1954809 | biostudies-literature | 2007 Aug

REPOSITORIES: biostudies-literature

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Publications

Amniotic membrane transplantation for ocular disease: a review of the first 233 cases from the UK user group.

Saw Valerie P J VP Minassian Darwin D Dart John K G JK Ramsay Andrew A Henderson Hugo H Poniatowski Stefan S Warwick Ruth M RM Cabral Suzanne S

The British journal of ophthalmology 20070221 8

<h4>Background</h4>Amniotic membrane transplantation (AMT), as a new tool in the armamentarium of therapies available for ocular surface problems, became widely available in the UK in 1998. This study evaluates the indications for treatment, the surgical procedures used, and the results of a subset of the first AMT cases carried out by the group using this nationally available supply. This user group model provides data which is different from that obtained from uncontrolled case series, or clin ...[more]

PMID: 17314154

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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.

Project description:Infectious keratitis (IK) is the 5th leading cause of blindness globally. Broad-spectrum topical antimicrobial treatment is the current mainstay of treatment for IK, though adjuvant treatment or surgeries are often required in refractory cases of IK. This systematic review aimed to examine the effectiveness and safety of adjuvant amniotic membrane transplantation (AMT) for treating IK. Electronic databases, including MEDLINE, EMBASE and Cochrane Central, were searched for relevant articles. All clinical studies, including randomized controlled trials (RCTs), non-randomized controlled studies and case series (n > 5), were included. Primary outcome measure was time to complete corneal healing and secondary outcome measures included corrected-distance-visual-acuity (CDVA), uncorrected-distance-visual-acuity (UDVA), corneal vascularization and adverse events. A total of twenty-eight studies (including four RCTs) with 861 eyes were included. When compared to standard antimicrobial treatment alone, adjuvant AMT resulted in shorter mean time to complete corneal healing (- 4.08 days; 95% CI - 6.27 to - 1.88; p < 0.001) and better UDVA (- 0.26 logMAR; - 0.50 to - 0.02; p = 0.04) at 1 month follow-up in moderate-to-severe bacterial and fungal keratitis, with no significant difference in the risk of adverse events (risk ratio 0.80; 0.46-1.38; p = 0.42). One RCT demonstrated that adjuvant AMT resulted in better CDVA and less corneal vascularization at 6 months follow-up (both p < 0.001). None of the RCTs examined the use of adjuvant AMT in herpetic or Acanthamoeba keratitis, though the benefit was supported by a number of case series. In conclusion, AMT serves as a useful adjuvant therapy in improving corneal healing and visual outcome in bacterial and fungal keratitis (low-quality evidence). Further adequately powered, high-quality RCTs are required to ascertain its therapeutic potential, particularly for herpetic and Acanthamoeba keratitis. Future standardization of the core outcome set in IK-related trials would be invaluable.

Dataset Information

Amniotic membrane transplantation for ocular disease: a review of the first 233 cases from the UK user group.

Background

Methods

Results

Conclusion

Publications

Amniotic membrane transplantation for ocular disease: a review of the first 233 cases from the UK user group.

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