Injectable Devices for Delivery of Liquid or Solid Protein Formulations.

Sustained delivery of protein therapeutics remains a largely unsolved problem across anatomic locations. Miniaturized devices that can provide sustained delivery of protein formulations have the potential to address this challenge via minimally invasive administration. In particular, methodologies that can optimize protein formulation independent of device manufacture have the greatest potential to provide a platform suitable for wide applications. The techniques developed here demonstrate the fabrication of tubular devices for sustained release of protein therapeutics. Utilizing a dip-casting process, fine-scale tubes can be reliably produced with wall thickness down to 30 µm. Techniques were developed that enabled effective loading of either solid or liquid formulations, while maintaining a cylindrical form-factor compatible with placement in a 22-gauge needle. Further, highly compacted protein pellets that approach the expected density of the raw materials were produced with a diameter (∼300 µm) suitable for miniaturized devices. Release from a solid-loaded device was capable of sustaining release of a model protein in excess of 400 days. Given significant interest in ocular applications, intravitreal injection was demonstrated in a rabbit model with these devices. In addition, to simulate repeated injections in ocular applications, serial intravitreal injection of two devices in a rabbit model demonstrated acceptable ocular safety without significant intraocular inflammation from clinical exam and histology.

The Vision Detroit Project: Integrated Screening and Community Eye-Health Education Interventions Improve Eyecare Awareness.

PURPOSE: Poor eye-health knowledge and health literacy are pervasive, contributing to worse outcomes. This study aims to examine short- and long-term eye-health knowledge retention following eye-health education interventions in adults. METHODS: Vision Detroit was an outreach vision screening program that integrated a 5-Point Teaching Intervention (5PTI), at a Southwest Community Center (SW-CC) from 2015-2017. The 5PTI consists of eye-health learning points developed to verbally educate patients. During vision screenings, eye-health knowledge tests were administered before and after 5PTI (Test 1 and Test 2, respectively). In 2016, Community Eye-Health Education Interventions (CHEI) were initiated at the SW-CC. During CHEI, bilingual healthcare students taught voluntary SW-CC members the 5PTI learning points, regardless of participant interest to attend future screenings. CHEI sessions occurred on separate dates prior to vision screening events. Test 1 and Test 2 scores were compared for all participants. Test 1 scores were compared for those who underwent CHEI prior to vision screening (CHEI positive) versus those who did not (CHEI negative). RESULTS: Two-hundred-seventeen adult patients met inclusion criteria, with 75.8% women, 82.6% Hispanic, mean age 50.4 ± 16.2 years, 74.6% had high school or less education, and 49.2% had health insurance. Test 1 to Test 2 scores improved after 5PTI (71.2 ± 26.4% vs. 97.2 ± 9.9%, p < .00001). Forty-eight participants attended CHEI and subsequent vision screening. Test 1 scores were higher among those CHEI positive versus CHEI negative (81.1 ± 2.1% vs. 68.3 ± 3.4%, p = .0027). CONCLUSION: Simple eye-health education interventions, delivered during vision screenings and via community-based education, can improve eye-health knowledge.

The Vision Detroit Project: Visual Burden, Barriers, and Access to Eye Care in an Urban Setting.

PURPOSE: Vision loss and blindness are among the top ten disabilities in the United States, yet access and utilization of eye care remains low. Vision Detroit aimed to address eye-care disparities via community-based screenings. By investigating burden of eye disease and barriers to eye-care utilization in an underserved urban community, we may direct efforts to improve access. METHODS: Twenty-three screenings were conducted from March 2015-November 2017. Patient information gathered at screenings were demographics, medical and social history, eye exam/referral history, insurance status, primary care physician (PCP) status, and patient-perceived eye-care barriers. RESULTS: Three-hundred-eighty patients were screened, 42% African American and 51% Hispanic. Average age was 53 ± 16.4 years, 70% reported vision problems, 50% reported over two years of vision problems, and average habitual visual acuity in best-seeing eye was 20/37. Eye-care underutilization was reported in 61% of type-2 diabetics. Older age and PCP recommendations/referrals were associated with increased utilization in all patients. Insurance was the most common barrier (53%); of the 55% insured, 31% reported financial barriers. Employed patients were more likely than unemployed to report a time barrier (odds ratio = 1.76, 95% confidence interval 1.03-3.01). Those with high school or less education reported "unaware of need", "unsure where to go", "transportation", and "insurance" as barriers more often. CONCLUSION: Visual burden was pervasive, yet access was suboptimal. Financial, logistical, and awareness barriers were common. PCP referral and older age were associated with increased utilization. Those less educated reported more barriers, highlighting the need to address fiscal concerns and eye-health education.