Capstone Week 2
This week we mainly focused on team brainstorming, deliverables 1 and 3, and more research on specific valves. Our posters used for brainstorming are shown below.
For Market Searches Research:
From the CDC:
-“About 3 million Americans have glaucoma. It is the second leading cause of blindness worldwide.”
-High-risk patients include: “African Americans over age 40, all people over age 60, people with a family history of glaucoma, and people who have diabetes. African Americans are 6 to 8 times more likely to get glaucoma than whites. People with diabetes are 2 times more likely to get glaucoma than people without diabetes.”
-A 2016 study found that 81% of glaucoma cases among Hispanics or Latinos are undiagnosed and untreated compared to 73% in non-Hispanic Whites.3 By the year 2050, it is expected that 50% of all glaucoma patients in the United States will be Hispanic.3
From Screening and Intervention for Glaucoma and Eye Health through Telemedicine:
-They do glaucoma screenings for intervention
To reach populations at high-risk for glaucoma and improve glaucoma detection and management among these populations through innovative outreach and service delivery models
From Incisional Surgery for Glaucoma:
-Incision based surgeries for Glaucoma are 70-90% successful for one year
From Distribution of Glaucoma Surgical Procedures in the United States:
-174,788 glaucoma surgeries performed: 22,862 trabeculectomies (13.1%), 19,991 GDI (11.4%) and 131,935 (75.5%) MIGS.
-People with Glaucoma: 0.5 million in 2010 to 79.6 million in 2020 and a projected 111.8 million by 2040
-“The Northeast region of the United States has a population of 9.4 million people older than 65 years, and a total of 34,558 glaucoma surgeries performed through Medicare in 2017”
From Magnetic Valve Research:
Constraints:
From “The Economic Evaluation of Medical Devices”
-four external factors that have a potential impact on economic evaluations of medical devices can be identified: (1) the regulatory environment for market approval, (2) the structure of the medical device industry, (3) the short product life-cycle, and (4) the early market diffusion of medical devices.
-Regarding the constraints to study design, an iterative approach to clinical assessment called the IDEAL method has been recommended for medical devices, which starts at an early point in product development and uses varying study designs
-Thus, if lack of data constitutes the primary obstacle of an economic evaluation, the question arises as to whether medical devices that lack comprehensive clinical evidence should undergo an economic evaluation. Taylor and Iglesias [60] therefore argue that the reimbursement of medical devices and pharmaceuticals is subject to the same budget constraints and should therefore meet the same requirements for appraisal.
-More importantly, greater awareness might serve as an impulse to formulate necessary changes at the regulatory level, to revisit methodological approaches to economic evaluations of medical devices and to optimize innovative reimbursement strategies in the future.
Chose top 3 strategies:
1. Dissolving valve, similar to the Ahmed valve, but resistance goes away after a certain amount of time in a linear fashion.
2. Magnetic-oriented valve that can control resistance
3. Valve similar to Ahmed, but where the elasticity lessens over time to provide less resistance.
Ahmed valve Surgery:
GV complications
-A report from the American Academy of Ophthalmology has reported the major short-term (up to 5 years after surgery) to medium-term (5–10 years after surgery) complications of aqueous shunt devices.43 They include immediate and late hypotony after surgery, excessive capsule fibrosis and clinical failure, erosion of the tube or plate edge, and very rarely infection.
Tube exposure
-Tube exposure is a well-known complication of glaucoma drainage implants (Figure 3). Erosion of the conjunctiva and of the covering patch graft has been described in the late postoperative period in 2%–7% of eyes after implantation of glaucoma devices.62,69–74 With regard to AGV, frequency of tube exposure varies from 5% to 14.3% of cases.63,75,76 In a recently published study on 12 patients, tube exposure has been encountered in up to 30.8% of cases.77 However, these high frequencies are not in accordance with data deriving from multicenter studies.
Corneal complications
-The presence of the silicone tube in the AC is known to disturb corneal endothelium and may induce corneal decompensation and edema.89 The exact frequency of corneal issues in patients implanted with AGV is not known, but it has been reported to be 9%–27% in the long term.89–91
Infection and endophthalmitis
-Endophthalmitis or infections associated with grafting material covering the tube is a rare complication of glaucoma drainage implants.
Diplopia and strabismus
-Diplopia and strabismus are well-known postsurgical complications of glaucoma drainage devices.43 The cause of diplopia is likely a restrictive strabismus, either from the plate itself or from the plate impinging on the muscle insertion.111 Manipulation of the rectus muscles during surgery may induce strabismus as well, which usually resolves spontaneously in weeks or months.63
This is a helpful video on the surgery for the Ahmed valve.
Size of Implantable Eye devices:
"From the Journal of Biomedical engineering “Thin-Film Coupled Fluid-Solid Analysis of Flow Through the Ahmed™ Glaucoma Drainage Device” was a great article to show mathematical equations relating to the ahmed valve."
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