scholarly journals Cost utility analysis of cryopreserved amniotic membrane versus topical cyclosporine for the treatment of moderate to severe dry eye syndrome

Author(s):  
Jeffrey Voigt

Abstract 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.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Waleed Alsarhani ◽  
Saeed Alshahrani ◽  
Mahmood Showail ◽  
Nawaf Alhabdan ◽  
Osama Alsumari ◽  
...  

Abstract Background This study described the clinical features of patients with pterygium and analyzed the recurrence rate of conjunctival autografting alone, conjunctival autografting combined with intraoperative mitomycin C, and amniotic membrane grafting. Methods A retrospective cohort study of primary pterygium was conducted between January 2017 and February 2020. Factors associated with pterygium severity and recurrence were analyzed by univariate analysis and logistic regression models. Results The study included 292 patients with an average age of 53.3 ± 14.1 years, while the number of operated cases was 94. Pterygia involving the cornea were observed in 55 % of the cases. The overall rate of recurrence for the three procedures was 17 %. The average time of recurrence was 14.2 ± 11.9 months, with 37 % of the recurrences occurring after the first year. The only factor associated with a significant risk of recurrence was dry eye disease in both univariate (p = 0.021) and multivariate analysis (p = 0.026). The recurrence rates following conjunctival autografting with and without mitomycin C were 15.6 and 15.8 %, respectively. The recurrence rate following the amniotic membrane graft was  twofold (OR= 2.02)  (27 %) that following the conjunctival autograft (15.8 %). Conclusions The only factor associated with the recurrence of pterygium was dry eye disease. More than one-third of recurrences developed after the first year, which stresses the importance of a long follow-up. The recurrence rate in our study following conjunctival graft was slightly higher compared to the literature mainly due to differences in study areas, populations, and follow-up periods.


2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  

Purpose The SANSIKA study evaluated the efficacy/safety of 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) for treating dry eye disease (DED) with severe keratitis. The double-masked phase demonstrated that CsA CE was effective in reducing corneal damage and ocular surface inflammation, and was well-tolerated over 6 months. Here we report efficacy and safety findings of SANSIKA's open-label extension (OLE). Methods In this multicenter, double-masked, phase III study, patients with severe DED (corneal fluorescein staining [CFS] grade 4, modified Oxford scale) were randomized to once-daily CsA CE (Ikervis®) or its vehicle for 6 months, followed by 6-month open-label, once-daily CsA CE (CsA CE/CsA CE and vehicle/CsA CE groups). Results A total of 177 patients completed the OLE. Efficacy results reiterated the double-masked phase: CsA CE reduced CFS score and human leukocyte antigen-antigen D related expression, improved corneal clearing, and produced continuous improvements in global symptom scores (ocular surface disease index [OSDI], visual analogue scale). The CFS-OSDI response rates (≥2 CFS points, ≥30% OSDI improvement vs baseline) at 12 vs 6 months were 39.1% vs 28.6%, respectively, for CsA CE/CsA CE and 38.0% vs 23.1% for vehicle/CsA CE. Cyclosporine A CE's safety profile was similar to the initial 6 months. The most common treatment-related treatment-emergent adverse event was instillation site pain (7.8%, CsA CE/CsA CE group; 19.0%, vehicle/CsA CE group). No unexpected safety signals were observed; systemic CsA levels were undetectable/negligible in all patients except 2 previously treated with systemic CsA. Conclusions In this 12-month study, once-daily CsA CE was well-tolerated and showed reductions in ocular surface inflammation and improvements in signs/symptoms in DED patients with severe keratitis.


2017 ◽  
Vol 27 (6) ◽  
pp. e194-e195
Author(s):  
Andrea Leonardi ◽  
Gysbert Van Setten ◽  
Mourad Amrane ◽  
Dahlia Ismail ◽  
Jean-Sebastien Garrigue ◽  
...  

2020 ◽  
Vol Volume 14 ◽  
pp. 931-938 ◽  
Author(s):  
Darrell E White ◽  
Yang Zhao ◽  
Hemalatha Jayapalan ◽  
Pattabhi Machiraju ◽  
Ramu Periyasamy ◽  
...  

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Thomas John ◽  
Sean Tighe ◽  
Hosam Sheha ◽  
Pedram Hamrah ◽  
Zeina M. Salem ◽  
...  

Purpose. To evaluate the efficacy of self-retained cryopreserved amniotic membrane (CAM) in promoting corneal nerve regeneration and improving corneal sensitivity in dry eye disease (DED).Methods. In this prospective randomized clinical trial, subjects with DED were randomized to receive CAM (study group) or conventional maximum treatment (control). Changes in signs and symptoms, corneal sensitivity, topography, and in vivo confocal microscopy (IVCM) were evaluated at baseline, 1 month, and 3 months.Results. Twenty subjects (age 66.9 ± 8.9) were enrolled and 17 completed all follow-up visits. Signs and symptoms were significantly improved in the study group yet remained constant in the control. IVCM showed a significant increase in corneal nerve density in the study group (12,241 ± 5083 μm/mm2at baseline, 16,364 ± 3734 μm/mm2at 1 month, and 18,827 ± 5453 μm/mm2at 3 months,p=0.015) but was unchanged in the control. This improvement was accompanied with a significant increase in corneal sensitivity (3.25 ± 0.6 cm at baseline, 5.2 ± 0.5 cm at 1 month, and 5.6 ± 0.4 cm at 3 months,p<0.001) and corneal topography only in the study group.Conclusions. Self-retained CAM is a promising therapy for corneal nerve regeneration and accelerated recovery of the ocular surface health in patients with DED. The study is registered at clinicaltrials.gov with trial identifier:NCT02764814.


Author(s):  
Dorota Kopacz ◽  
Łucja Niezgoda ◽  
Ewa Fudalej ◽  
Anna Nowak ◽  
Piotr Maciejewicz

The tear film is a thin fluid layer covering the ocular surface. It is responsible for ocular surface comfort, mechanical, environmental and immune protection, epithelial health and it forms smooth refractive surface for vision. The traditional description of the tear film divides it into three layers: lipid, aqueous and mucin. The role of each layer depends on the composition of it. Tear production, evaporation, absorption and drainage concur to dynamic balance of the tear film and leads to its integrity and stability. Nonetheless, this stability can be disturb in tear film layers deficiencies, defective spreading of the tear film, in some general diseases and during application of some general and/or topical medications. Dry eye disease is the result of it. In this review not only physiology of the tear film is presented. Moreover, we would like to discuss the influence of various diseases and conditions on the tear film and contrarily, spotlight tear film disorders as a manifestation of those diseases.


2020 ◽  
Vol Volume 14 ◽  
pp. 875-883 ◽  
Author(s):  
Darrell E White ◽  
Yang Zhao ◽  
Hemalatha Jayapalan ◽  
Pattabhi Machiraju ◽  
Ramu Periyasamy ◽  
...  

2018 ◽  
Vol 7 (5) ◽  
pp. 24 ◽  
Author(s):  
Terry G. Coursey ◽  
Ronald A. Wassel ◽  
Alexander B. Quiambao ◽  
Rafal A. Farjo

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