Dataset Information

Accelerated Restoration of Ocular Surface Health in Dry Eye Disease by Self-Retained Cryopreserved Amniotic Membrane.

ABSTRACT: To evaluate the clinical efficacy of self-retained cryopreserved amniotic membrane in treating dry eye disease.Retrospective review of 10 patients treated with self-retained cryopreserved amniotic membrane (PROKERA® Slim [PKS], Bio-Tissue, Miami, FL) for moderate-to-severe dry eye refractory to conventional maximal medical treatments. Patients' symptoms, use of medications, conjunctival inflammation, corneal staining, and visual acuity were compared before and after treatment.PKS was placed in 15 eyes of the 10 patients for 4.9 ± 1.5 days. All patients experienced symptomatic relief for a period of 4.2 ± 4.7 months (P<.001). Such improvement was accompanied by reduction of OSDI scores (P<.001), use of topical medications (P<.001), conjunctival hyperemia (P<.001), corneal staining (P<.001), and improvement of the visual acuity (P=.06). Linear regression analysis estimated that the optimal duration of PKS placement was 5 days to achieve an average symptom-free duration of 4 months in patients with dry eye. Surprisingly, PKS placement also generated improvement in the contralateral eyes.This pilot study suggests that self-retained cryopreserved amniotic membrane via PKS can be used to treat moderate dry eye diseases and warrants further prospective controlled studies.

SUBMITTER: Cheng AM

PROVIDER: S-EPMC4706470 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Accelerated Restoration of Ocular Surface Health in Dry Eye Disease by Self-Retained Cryopreserved Amniotic Membrane.

Cheng Anny M S AM Zhao Dandan D Chen Rendian R Yin Han Y HY Tighe Sean S Sheha Hosam H Casas Victoria V Tseng Scheffer C G SC

The ocular surface 20150924 1

<h4>Purpose</h4>To evaluate the clinical efficacy of self-retained cryopreserved amniotic membrane in treating dry eye disease.<h4>Methods</h4>Retrospective review of 10 patients treated with self-retained cryopreserved amniotic membrane (PROKERA® Slim [PKS], Bio-Tissue, Miami, FL) for moderate-to-severe dry eye refractory to conventional maximal medical treatments. Patients' symptoms, use of medications, conjunctival inflammation, corneal staining, and visual acuity were compared before and aft ...[more]

PMID: 26387870

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Project description:Background: The purpose is to perform a cost effectiveness analysis amniotic membrane vs. topical medications in the use of treating dry eye disease. A cost effectiveness analysis comparing amniotic membrane?+?other topical medications to topical cyclosporine A?+?other topical medications was evaluated using accepted decision tree modeling software.Methods: TreeAge Pro 2019 software was used to evaluate the base case costs over a one year timeframe. Sensitivity analysis was performed on those variables which had the greatest effect on choosing one therapy versus the other based on cost. Monte Carlo simulation was run 1,000 times to determine the most effective, least costly alternative. Costs were evaluated from a societal level (direct?+?indirect). Quality of life utility scores were evaluated using known time tradeoffs from prior studies (scale 0-1; with 1 being perfect vision).Results: Over a one year timeframe, the base case demonstrated that amniotic membrane?+?topical medications was the less expensive alternative and provided for incremental utilities versus topical cyclosporine?+?other medications (Cost/utility: $18,275/0.78 vs. $20,740/0.74). If examining direct costs only, topical cyclosporine was the least expensive option over a one year timeframe: $4,112 vs. $10,300. Sensitivity analysis demonstrated that in order for topical cyclosporine to be the less expensive alternative the following variables would need to be:?<?68 days productivity lost;?<?$161 productivity lost/day;?>?79% of amniotic membrane implants would need to be re-implanted at month 4 (for whatever reason);?>?$2677 per amniotic membrane implant procedure (Medicare reimbursement rate);?>?96% positive response to topical cyclosporine A at month 4;?>?58% positive response to topical cyclosporine A at month 6 and;?<?54% probability clinical improvement with amniotic membrane. Monte Carlo simulation demonstrated that amniotic membrane was the less costly, most effective alternative 91.5% of the time.Conclusion: Based on improved outcomes using amniotic membrane, patient productivity was improved resulting in lower societal costs (less days lost from work). When considering the untoward effects of dry eye disease on societal costs, an improvement of the dry eye disease condition was accomplished most often with amniotic membrane.

Project description:Dry eye disease can be a consequence of lacrimal gland insufficiency in Sjögren's Syndrome or increased tear film evaporation despite normal lacrimal gland function. To determine if there is a correlation between severity effects in these models and underlying pathophysiological responses, we compared the time dependent changes in each of these parameters that occur during a 6 week period. Dry eye was induced in 6-week-old female C57BL/6 mice by exposing them to an Intelligently Controlled Environmental System (ICES). Sixty mice were housed in ICES for 1, 2, 4 and 6 weeks respectively. Twelve were raised in normal environment and received subcutaneous injections of scopolamine hydrobromide (SCOP) 3 times daily for 5 days. Another sixty mice were housed in a normal environment and received no treatment. Corneal fluorescein staining along with corneal MMP-9 and caspase-3 level measurements were performed in parallel with the TUNEL assay. Interleukin-17(IL-17), IL-23, IL-6, IL-1, TNF-α, IFN-γ and TGF-β2 levels were estimated by real-time PCR measurements of conjunctival and lacrimal gland samples (LGs). Immunohistochemistry of excised LGs along with flow cytometry in cervical lymph nodes evaluated immune cell infiltration. Light and transmission electron microscopy studies evaluated LGs cytoarchitectural changes. ICES induced corneal epithelial destruction and apoptosis peaked at 2 weeks and kept stable in the following 4 weeks. In the ICES group, lacrimal gland proinflammatory cytokine level increases were much lower than those in the SCOP group. In accord with the lower proinflammatory cytokine levels, in the ICES group, lacrimal gland cytosolic vesicular density and size exceeded that in the SCOP group. ICES and SCOP induced murine dry eye effects became progressively more severe over a two week period. Subsequently, the disease process stabilized for the next four weeks. ICES induced local effects in the ocular surface, but failed to elicit lacrimal gland inflammation and cytoarchitectural changes, which accounts for less dry eye severity in the ICES model than that in the SCOP model.

Dataset Information

Accelerated Restoration of Ocular Surface Health in Dry Eye Disease by Self-Retained Cryopreserved Amniotic Membrane.

Publications

Accelerated Restoration of Ocular Surface Health in Dry Eye Disease by Self-Retained Cryopreserved Amniotic Membrane.

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