Survey of perspectives of people with inherited retinal diseases on ocular gene therapy in Australia.

Many gene therapies are in development for treating people with inherited retinal diseases (IRD). We hypothesized that potential recipients of gene therapy would have knowledge gaps regarding treatment. We aimed to assess knowledge, attitudes, and perceptions of genetic therapies among potential recipients with IRD, using a novel instrument we designed (Attitudes to Gene Therapy-Eye (AGT-Eye)) and their associations with demographic data, self-reported visual status, and tools assessing quality of life and attitudes toward clinical trials using a community-based cross-sectional survey of Australian adults with IRD. AGT-Eye, overall quality of life EQ-5D-5L, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) and Patient Attitudes to Clinical Trials (PACT-22) instruments were administered. Six hundred and eighty-one people completed the study, 51.7% women of mean age 53.5 years (SD ± 15.8). Most participants (91.6%) indicated they would likely accept gene therapy if it was available to them or family members. However, only 28.3% agreed that they had good knowledge of gene therapy. Most obtained information about gene therapy from the internet (49.3%). Respondents with post-graduate degrees scored highest compared to other educational levels on methods (p < 0.001) and outcomes (p = 0.003) and were more likely to see economic value of treatment (p = 0.043). Knowledge gaps were present regarding methods and outcomes of gene therapy. This survey has shown high level of interest in the IRD community for gene therapies, and highlights areas for improved clinician and patient education.

The safety and efficacy of gene therapy treatment for monogenic retinal and optic nerve diseases: A systematic review.

PURPOSE: This study aimed to systematically review and summarize gene therapy treatment for monogenic retinal and optic nerve diseases. METHODS: This review was prospectively registered (CRD42021229812). A comprehensive literature search was performed in Ovid MEDLINE, Ovid Embase, Cochrane Central, and clinical trial registries (February 2021). Clinical studies describing DNA-based gene therapy treatments for monogenic posterior ocular diseases were eligible for inclusion. Risk of bias evaluation was performed. Data synthesis was undertaken applying Synthesis Without Meta-analysis guidelines. RESULTS: This study identified 47 full-text publications, 50 conference abstracts, and 54 clinical trial registry entries describing DNA-based ocular gene therapy treatments for 16 different genetic variants. Study summaries and visual representations of safety and efficacy outcomes are presented for 20 unique full-text publications in RPE65-mediated retinal dystrophies, choroideremia, Leber hereditary optic neuropathy, rod-cone dystrophy, achromatopsia, and X-linked retinoschisis. The most common adverse events were related to lid/ocular surface/cornea abnormalities in subretinal gene therapy trials and anterior uveitis in intravitreal gene therapy trials. CONCLUSION: There is a high degree of variability in ocular monogenic gene therapy trials with respect to study design, statistical methodology, and reporting of safety and efficacy outcomes. This review improves the accessibility and transparency in interpreting gene therapy trials to date.

Victorian evolution of inherited retinal diseases natural history registry (VENTURE study): Rationale, methodology and initial participant characteristics.

BACKGROUND: Emerging treatments are being developed for inherited retinal diseases, requiring a clear understanding of natural progression and a database of potential participants for clinical trials. This article describes the rationale, study design and methodology of the Victorian Evolution of inherited retinal diseases NaTUral history REgistry (VENTURE), including data from the first 150 participants enrolled. METHODS: VENTURE collects retrospective and prospective data from people with inherited retinal diseases. Following registration, participants are asked to attend a baseline examination using a standardised protocol to confirm their inherited retinal disease diagnosis. Examination procedures include (i) retinal function, using visual acuity and perimetry; (ii) retinal structure, using multimodal imaging and (iii) patient-reported outcomes. Participants' molecular diagnoses are obtained from their clinical records or through targeted-panel genetic testing by an independent laboratory. Phenotype and genotype data are used to enrol participants into disease-specific longitudinal cohort sub-studies. RESULTS: From 7 July 2020 to 30 December 2021, VENTURE enrolled 150 registrants (138 families) and most (63%) have a rod-cone dystrophy phenotype. From 93 participants who have received a probable molecular diagnosis, the most common affected genes are RPGR (13% of all registrants), USH2A (10%), CYP4V2 (7%), ABCA4 (5%), and CHM (5%). Most participants have early to moderate vision impairment, with over half (55%) having visual acuities of better than 6/60 (20/200) at registration. CONCLUSIONS: The VENTURE study will complement existing patient registries and help drive inherited retinal disease research in Australia, facilitating access to research opportunities for individuals with inherited retinal diseases.

Comparing two methods for delivering clinical trial informed consent information to older adults: singular versus stepped approach.

BACKGROUND: Adapting the informed consent process to the needs of older adults may enhance engagement and willingness to participate in a clinical trial. A key aspect of the process is being provided with written clinical trial information and consent documents and having an opportunity to discuss the information with the researcher. However, there are no guidelines on the most appropriate method for delivering this information to older adults and it is not known whether the delivery method is a facilitator or barrier towards clinical trial participation. AIMS: To compare two delivery methods of informed consent on recruitment, refusal to continue and randomisation rates in a general practice-based clinical trial involving older adults. METHODS: In a matched cohort sub-study as part of the STAtins in Reducing Events in the Elderly clinical trial, 520 participants were allocated into two groups by age, gender and attending general practice location, to receive the trial information and consent form in the mail (Method 1) prior to the first baseline visit or in person (Method 2) at the visit where a comprehensive informed consent process took place. RESULTS: Compared with Method 1, potential participants assigned to Method 2 were more likely to agree to attend the first baseline screening visit (refusal rate 20% vs 13.5%, respectively, p = 0.05). However, there was no significant difference in the proportion of participants recruited into the trial by providing written informed consent at the first baseline screening visit. For each informed consent delivery method, similar proportions of participants refused to take part in the trial by the end of the screening phase. Randomisation rates in the two groups were also similar. Time to conduct the informed consent procedure took significantly longer with Method 2 compared with Method 1 (median time 20 vs 15 min, respectively, p < 0.01). Interest in the research trial topic was the main reason cited (33.4%) for considering trial participation. CONCLUSION: Later delivery of informed consent documents to potential participants in this trial was associated with a small increase in attendance at the first, in person, screening visit. However, the randomisation rate of participants into the trial was not affected by the method and timing of delivery of informed consent information. Similar randomisation rates occurred whether potential participants were mailed informed consent documents prior to the first in person screening visit or were given the information at the screening visit.

Rasch Analysis of the Independent Mobility Questionnaire.

PURPOSE: The Independent Mobility Questionnaire (IMQ) assesses participants' perceived ability for independent mobility. However, it has not been validated in a severely visually impaired population. The aim of this study was to explore the IMQ's psychometric properties in participants with severe visual impairment. METHODS: This was a cross-sectional study of 40 participants with retinitis pigmentosa (better eye visual acuity <20/200 and/or visual field <10%). The key psychometric properties of the IMQ were examined using Rasch analysis, including precision, targeting, and item fit. Construct validity was assessed by testing the correlation between the IMQ and the Mobility and Independence subscale of the Impact of Vision Impairment questionnaire (Pearson correlation coefficient, r). Criterion validity was also assessed. RESULTS: The IMQ had excellent precision (Person Separation Index, 3.01) with the capacity to distinguish at least four strata of participant ability, and item difficulty was well targeted to participant ability (difference between mean person and item measures, -0.21). Items 34, 35, 21, and 14 displayed misfit (infit MnSq >1.4); however, given our sample size restrictions, these items were not removed from the analysis. The IMQ had good construct validity (moderate correlation with the Impact of Vision Impairment Mobility subscale, r = 0.595, p < 0.05) but did not demonstrate criterion validity. CONCLUSIONS: The psychometric properties of the IMQ were promising. Our findings are useful for researchers evaluating the effectiveness of novel treatment technologies on mobility in a severely visually impaired population from the participant's perspective. However, further validation studies in larger samples are required to confirm our results.

Developing a Very Low Vision Orientation and Mobility Test Battery (O&M-VLV).

PURPOSE: This study aimed to determine the feasibility of an assessment of vision-related orientation and mobility (O&M) tasks in persons with severe vision loss. These tasks may be used for future low vision rehabilitation clinical assessments or as outcome measures in vision restoration trials. METHODS: Forty legally blind persons (mean visual acuity logMAR 2.3, or hand movements) with advanced retinitis pigmentosa participated in the Orientation & Mobility-Very Low Vision (O&M-VLV) subtests from the Low Vision Assessment of Daily Activities (LoVADA) protocol. Four categories of tasks were evaluated: route travel in three indoor hospital environments, a room orientation task (the "cafe"), a visual exploration task (the "gallery"), and a modified version of the Timed Up and Go (TUG) test, which assesses re-orientation and route travel. Spatial cognition was assessed using the Stuart Tactile Maps test. Visual acuity and visual fields were measured. RESULTS: A generalized linear regression model showed that a number of measures in the O&M-VLV tasks were related to residual visual function. The percentage of preferred walking speed without an aid on three travel routes was associated with visual field (p < 0.01 for all routes) whereas the number of contacts with obstacles during route travel was associated with acuity (p = 0.001). TUG-LV task time was associated with acuity (p = 0.003), as was the cafe time and distance traveled (p = 0.006 and p < 0.001, respectively). The gallery score was the only measure that was significantly associated with both residual acuity and fields (p < 0.001 and p = 0.001, respectively). CONCLUSIONS: The O&M-VLV was designed to capture key elements of O&M performance in persons with severe vision loss, which is a population not often studied previously. Performance on these tasks was associated with both binocular visual acuity and visual field. This new protocol includes assessments of orientation, which may be of benefit in vision restoration clinical trials.

Sociodemographic factors and utilization of eye care services: is there an association with patients presenting to a tertiary referral hospital in acute angle-closure?

BACKGROUND: The aim of this study is to examine the relationship between sociodemographic factors and utilization of eye care services in patients presenting in acute angle-closure (AAC). DESIGN: A hospital-based retrospective, case-control study. PARTICIPANTS: Fifty-five patients consecutively presenting to the emergency department of the Royal Victorian Eye and Ear Hospital with AAC (cases), and 43 patients consecutively referred to the outpatient department for prophylactic laser peripheral iridotomy (controls) over a 3-year period. METHODS: Standardized telephone questionnaires. MAIN OUTCOME MEASURES: Comparisons were made for sociodemographic factors, utilization of eye care services and provision of information on glaucoma and premonitory symptoms of AAC. RESULTS: No significant differences across a range of socioeconomic and demographic factors were found. Fewer cases reported having attended an eye care professional ever (P = 0.02), or in the 12 months preceding their acute hospital attendance (P = 0.002), and had less awareness of angle closure glaucoma (P = 0.001). Logistic regression modelling demonstrated premonitory symptoms of AAC (odds ratio 3.96, [95% confidence interval 1.52-10.32], P < 0.001) and a period of greater than 12 months since the last eye examination (odds ratio 3.89, [95% confidence interval 1.64-9.21]) were significantly associated with the risk of AAC. CONCLUSIONS: No significant differences in socioeconomic or demographic parameters between cases and controls were identified. Control subjects had a history of more frequent and recent access to eye care services than cases. The finding that more than one-third of patients presenting with AAC had consulted an eye care provider in the preceding year suggests that a significant proportion of individuals at risk of AAC remain undetected.

Awareness of Usher Syndrome and the Need for Multidisciplinary Care: A Cross-Occupational Survey of Allied Health Clinicians.

Background: Usher syndrome is the most common cause of deaf-blindness, affecting up to 1 in 6000 people. Multidisciplinary care is required to maximize outcomes for individuals and families. This study assessed awareness of Usher Syndrome amongst allied health clinicians who provide care related to the primarily affected senses of hearing and vision, ie, optometry, orthoptics and audiology. Methods: A prospective cross-sectional online survey of clinicians working in Australian university-affiliated clinics (7 optometry, 1 orthoptics and 4 audiology) was completed between September 2021 and January 2022. Questions were asked about the cause, common symptoms, and awareness of health professions who manage Usher syndrome. Results: The 27 audiologists, 40 optometrists, and 7 orthoptists who completed the survey included 53 females (71.6%), had an average age of 37 years (range 24-70), and had an average duration of clinical experience of 13 years (range 1-45 years). The majority of respondents correctly identified Usher syndrome as a genetic condition (86%), identified at least two of the affected senses (97%), and identified the progressive nature of the vision and hearing losses (>90%). Awareness of vestibular dysfunction and its characteristics was low, as was knowledge of the key treatment roles that speech pathologists, genetic counsellors and geneticists play in the management of Usher Syndrome. The majority of respondents also did not identify important aspects of care within their own discipline. Conclusion: This study has shown that there is a need for targeted education to be delivered to hearing and vision care allied health clinicians to raise awareness of the vestibular impacts and aspects of vision loss experienced by people with Usher syndrome. This education needs to target the broad range of clinicians who have a key role in providing multidisciplinary care (including speech pathologists, geneticists, and genetic counsellors) and to identify the key aspects of good-quality multidisciplinary care.

Is primary open-angle glaucoma part of a generalized sensory neurodegeneration? A review of the evidence.

Open-angle glaucoma is an optic neuropathy that has a multifarious aetiological profile. Emerging theories suggest that a group of factors induce optic nerve injury in innately susceptible aging optic nerves. These factors have the potential to impact on the function of other vulnerable neurons within the central nervous system of older patients. Although changes within the visual pathways due to retinal ganglion cell dysfunction and death are well established, research exploring the behaviour of other sensory systems in individuals with glaucoma is limited. This review summarizes what is known about these other non-visual sensory changes, explores whether glaucoma is in fact part of a global neurodegenerative condition, and suggests areas for future research direction.

Prevalence of signs and symptoms of ocular surface disease in individuals treated and not treated with glaucoma medication.

BACKGROUND: To determine the prevalence of signs and symptoms of ocular surface disease in two hospital-based cohorts; glaucoma patients and non-glaucoma patients. DESIGN: A cross-sectional, comparative case series. PARTICIPANTS: Glaucoma patients (n = 300) prescribed topical glaucoma medications for ≥6 months were compared with control patients (n = 100) who were not applying prescribed topical medications. METHODS: A validated self-report questionnaire was used to elicit the extent of ocular symptoms. Signs of ocular surface and eyelid disease were assessed along with medication history. MAIN OUTCOME MEASURES: Signs and symptoms of ocular surface pathology were determined including the tear film break-up time, fluorescein staining of the cornea and conjunctiva, meibomian gland dysfunction and Schirmer's test. RESULTS: A significant increase in the prevalence of ocular surface disease signs was observed in the glaucoma population, 70.3%, compared with controls, 33% (P < 0.001). The overall prevalence of clinically significant ocular surface disease symptoms was not significantly different between cohorts, 30.7% versus 24.0%, respectively (P = 0.252). Logistic regression analysis showed that the number of anti-glaucoma medications and duration of therapy were key predictors of significant ocular surface disease signs in the glaucoma group. There was no significant correlation between signs and symptoms of ocular surface disease in either group after adjusting for age and gender. CONCLUSIONS: Signs and symptoms of ocular surface disease are relatively common in older patients, but signs of ocular surface disease are significantly higher in individuals who instil topical glaucoma therapy.

Auditory processing deficits in individuals with primary open-angle glaucoma.

OBJECTIVE: The high energy demand of the auditory and visual pathways render these sensory systems prone to diseases that impair mitochondrial function. Primary open-angle glaucoma, a neurodegenerative disease of the optic nerve, has recently been associated with a spectrum of mitochondrial abnormalities. This study sought to investigate auditory processing in individuals with open-angle glaucoma. DESIGN/STUDY SAMPLE: Twenty-seven subjects with open-angle glaucoma underwent electrophysiologic (auditory brainstem response), auditory temporal processing (amplitude modulation detection), and speech perception (monosyllabic words in quiet and background noise) assessment in each ear. A cohort of age, gender and hearing level matched control subjects was also tested. RESULTS: While the majority of glaucoma subjects in this study demonstrated normal auditory function, there were a significant number (6/27 subjects, 22%) who showed abnormal auditory brainstem responses and impaired auditory perception in one or both ears. CONCLUSIONS: The finding that a significant proportion of subjects with open-angle glaucoma presented with auditory dysfunction provides evidence of systemic neuronal susceptibility. Affected individuals may suffer significant communication difficulties in everyday listening situations.

Intereye Symmetry in Bietti Crystalline Dystrophy.

PURPOSE: To evaluate anatomic and functional intereye symmetry among individuals with Bietti crystalline dystrophy (BCD) using clinical and multimodal imaging methods, with a focus on the number, area, and distribution of the characteristic retinal crystalline deposits. DESIGN: Observational case series with prospective and retrospective data. METHODS: Setting: Multicenter. STUDY POPULATION: Thirteen Australian and New Zealand participants (26 eyes) with confirmed biallelic CYP4V2 mutations and a characteristic BCD fundus appearance. Procedures and main outcome measures: Crystals visible on color fundus photography were manually counted. Crystals were superimposed on aligned multimodal fundus images. Spearman's correlation coefficients (ρ), intraclass correlation coefficients (ICCs), and Bland-Altman plots were used to quantify symmetry between eyes. MAIN OUTCOME MEASURES: Fundus crystal area and count, and absent-autofluorescence (absent-AF) area. RESULTS: Median participant age was 48 years (interquartile range: 40-60 years). Intereye symmetry was high for fundus crystal area (ρ = 1.00, 95% confidence interval [CI]: 1.00-1.00; ICC = 0.97, 95% CI: 0.88-0.99), fundus crystal count (ρ = 0.98, 95% CI: 0.92-1.00; ICC = 0.97, 95% CI: 0.89-0.99), and absent-AF area (ρ = 0.88, 95% CI: 0.53-0.98; ICC = 0.98, 95% CI: 0.90-0.99). Average foveal volume, foveal crystal count and area, average and central foveal thickness, best corrected visual acuity, and average macular and central foveal sensitivity were not highly correlated between eyes. CONCLUSIONS: This study demonstrated strong intereye symmetry measured by fundus crystal area, fundus crystal number, and absent-AF area. This may influence the choice of outcome measures for future therapeutic trials for BCD and provides valuable clinical information for ophthalmologists involved in the care and counseling of patients with BCD.

The association of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio with retinal vein occlusion: a systematic review and meta-analysis.

The neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) are emerging haematological inflammatory biomarkers. However, their significance in retinal vein occlusion (RVO) and its subtypes, branch and central RVO (BRVO and CRVO, respectively), is uncertain. This systematic review and meta-analysis aimed to clarify the association of NLR and PLR with RVO. We searched MEDLINE (Ovid), EMBASE (Ovid) and the Cochrane Library for studies investigating the association of NLR and PLR with RVO from inception to 2 December 2020. We used random-effects inverse-variance modelling to generate pooled effect measures. We used bivariate Bayesian modelling to meta-analyse the ability of NLR and PLR to differ between individuals with and without RVO and performed meta-regression and sensitivity analyses to explore inter-study heterogeneity. Eight studies published encompassing 1059 patients were included for analysis. Both NLR and PLR were significantly elevated in RVO, with pooled mean differences of 0.63 (95% confidence interval (CI) 0.31-0.95) and 21.49 (95% CI 10.03-32.95), respectively. The pooled sensitivity, specificity and area under the Bayesian summary receiver operating characteristic curve were, respectively, 0.629 (95% credible interval (CrI) 0.284-0.872), 0.731 (95% CrI 0.373-0.934) and 0.688 (95% CrI 0.358-0.872) for NLR; and 0.645 (95% CrI 0.456-0.779), 0.616 (95% CrI 0.428-0.761) and 0.621 (95% CrI 0.452-0.741) for PLR. Mean and variability of age and diabetes mellitus prevalence partially explained between-study heterogeneity. NLR and PLR are significantly elevated in RVO. Future research is needed to investigate the potential prognostic value and independence of these findings.

Gene therapy for inherited retinal diseases: progress and possibilities.

Inherited retinal diseases (IRDs) comprise a heterogeneous group of genetic disorders affecting the retina. Caused by mutations in over 300 genes, IRDs result in visual impairment due to dysfunction and degeneration of photoreceptors, retinal pigment epithelium, or the choroid. Important photoreceptor IRDs include retinitis pigmentosa and Leber congenital amaurosis. Macular dystrophies include Stargardt and Best disease. Currently, IRDs are largely incurable but the landscape of treatment options is rapidly changing for these diseases which, untreated, result in severe visual impairment and blindness.Advances in DNA delivery to the retina and improved genetic diagnosis of IRDs have led to a new era of research into gene therapy for these vision-threatening disorders. Gene therapy is a compelling approach due to the monogenic nature of most IRDs, with the retina being a favourable target for administering genetic vectors due to its immunoprivileged environment, direct visibility, and multiple methods to assess sensitivity and function. Generally, retinal gene therapy involves a subretinal or intravitreal injection of a viral vector, which infects target cells to deliver a therapeutic gene, or transgene. A gene augmentation strategy introduces a functioning copy of a gene to restore expression of a mutated gene, whereas a gene-editing strategy aims to directly edit and correct the mutation. Common delivery vectors include adeno-associated virus (AAV) and lentivirus.Voretigene neparvovec-rzyl (Luxturna) became the first FDA-approved direct gene therapy in December 2017, and the Australian TGA followed suit in August 2020. More are projected to follow, with clinical trials underway for many other IRDs.This review provides an overview of gene therapy for IRDs, including current progress and challenges. A companion article in this issue details target patient populations for IRD gene therapy, and how optometrists can assist in assessing individuals who may be eligible for current and future therapies.

Perspectives of people with inherited retinal diseases on ocular gene therapy in Australia: protocol for a national survey.

INTRODUCTION: Voretigene neparvovec-rzyl (Luxturna) was approved by the Australian Therapeutic Goods Administration on 4 August 2020 for the treatment of biallelic mutations in the RPE65 gene, a rare cause of congenital and adult-onset retinal dystrophy (predominantly Leber congenital amaurosis). Previous studies have shown that individuals who might participate in gene therapy trials overestimate clinical effect and underestimate risks. However, little is known about the perspectives of patients who may be offered approved gene therapy treatment for ocular conditions (as distinct from participating in clinical trials of gene therapy). The main objective of this study is to develop a tool to assess knowledge, attitudes and perceptions of approved and future genetic therapies among potential recipients of ocular gene therapy. In addition, we aim to assess the quality of life, attitudes towards clinical trials and vision-related quality of life among this cohort. METHODS AND ANALYSIS: A new 'Attitudes to Gene Therapy for the Eye' tool will be developed following consultation with people with inherited retinal disease (IRD) and content matter experts. Australians with IRD or their guardians will be asked to complete an internet-based survey comprising existing quality of life and visual function instruments and items for the newly proposed tool. We expect to recruit 500 survey participants from patient support groups, the practices of Australian ophthalmologists who are specialists in IRD and Australian ophthalmic research institutions. Launch is anticipated early 2021. Responses will be analysed using item response theory methodology. ETHICS AND DISSEMINATION: This study has received ethics approval from the University of Melbourne (#2057534). The results of the study will be published in a peer-reviewed journal and will be presented at relevant conferences. Organisations involved in recruitment, and the Patient Engagement Advisory committee will assist the research team with dissemination of the study outcomes.

An optometrist's guide to the top candidate inherited retinal diseases for gene therapy.

This review presents the phenotypic and genotypic profiles of a select group of inherited retinal diseases (IRDs) that are currently the focus of retinal gene therapy trials globally. Research progress in IRD treatment trials may soon lead to their availability in Australia and New Zealand, as either approved treatment or a clinical trial. The salient clinical characteristics of retinitis pigmentosa-the largest IRD category-are highlighted, with specific reference to RPE65-associated Leber congenital amaurosis, followed by other specific IRDs, namely choroideremia and ABCA4-associated Stargardt disease. These IRDs are selected based on their candidacy for gene therapy. Guidance on the clinical diagnostic tests that support each of these diagnoses will be presented. More broadly, the most useful structure and function measures to monitor IRD progression is discussed, along with the key assessments that offer differential diagnostic insight. This review is intended to be a clinical guide for optometrists, to assist in assessment and management of individuals who may be eligible for current and future gene therapies. A companion article in this issue will provide an overview of the basic principles of gene therapy and its development as a new treatment for inherited retinal diseases.

Readability of prescription labels and medication recall in a population of tertiary referral glaucoma patients.

PURPOSE: To evaluate readability of eye drop labels and accurate recall of prescription instructions in a glaucoma population. METHODS: A hospital-based, cross-sectional study. A trained, interviewer examined patient ability to read standard and larger font medication labels. A questionnaire was administered to ascertain accurate recall of prescribed eye drops. Clinical information was obtained through independent chart review. Glaucoma severity was classified according to a glaucoma staging system. The setting for the study was the glaucoma outpatient clinic, Royal Victorian Eye and Ear Hospital (Melbourne, Australia), a major tertiary referral centre. A total of 200 glaucoma patients (96.2% response), aged 45-90 years, on eye drops took part in the study. Non-English-speaking patients were excluded. The main outcome measure was the ability to read prescribed medication labels and accurately recall treatment regime was compared with glaucoma severity and the number of eye drops. RESULTS: Of the glaucoma patients, 12% were unable to read standard pharmacy labels. Only 5.5% were unable to read the larger font labels. Of the patients, 32% were not able to accurately recall the type of drops or prescribed frequency of instillation. An inability to read standard labels was associated with a threefold reduction in the likelihood of accurate medication recall (95% confidence intervals, 1.40-7.66, P < 0.05). Patients with three or more types of eye drops were five times less likely to recall their medications (95% confidence interval, 0.07-0.57, P < 0.05). CONCLUSIONS: Inability to read or recall prescribed eye drops was associated with glaucoma severity and the number of prescribed eye drops. These factors may impact significantly on patients' adherence to glaucoma medications.

Psychosocial assessment of potential retinal prosthesis trial participants.

BACKGROUND: As the field of retinal prostheses advances, volunteers are required for device trials, and optimal participant recruitment is vital for intervention success. The aims of this study were: (i) to select tests that assess the psychosocial aspects of visual impairment and develop a psychosocial assessment protocol for persons who may be eligible for participation in retinal prostheses trials; (ii) to investigate correlations between these tests; and (iii) to determine associations between psychosocial factors and a person's interest in participating in a retinal prosthesis (bionic eye) trial. METHODS: Cross-sectional study of 72 adults with advanced retinal degeneration. Questionnaire assessments included personality, cognitive ability, social-support, self-efficacy, coping, optimism, depression, and quality of life (Impact of Vision Impairment Profile ([IVI], and Vision and Quality of Life Index [VisQoL]). Level of interest in a retinal prosthesis was also evaluated. RESULTS: All questionnaires were completed without floor or ceiling effects and with minimal respondent burden. Depression correlated with decreased quality of life (rho = -0.37 and 0.40, p < 0.001 for IVI and VisQoL, respectively). Together, depression, gender and vision-specific coping explained 35.2 per cent of variance in IVI quality of life (p < 0.001). Forty-nine per cent of participants were interested in a retinal prosthesis now and 77 per cent in the future. Although the personality trait of 'openness' was somewhat predictive of interest in retinal prostheses (odds ratio 0.78, 95% CI 0.62-0.97), neither severity of vision impairment nor any of the psychosocial measures were strong predictors. CONCLUSIONS: Several existing psychosocial questionnaires can be used for patients with advanced retinal degeneration and may be useful in exploring suitability for a retinal prosthesis or evaluating outcomes. However, the questionnaires used in this study were not good predictors of whether or not a person might be interested in a retinal prosthesis.

Impact of informed consent content and length on recruitment of older adults into a community based primary prevention trial.

AIMS: To compare recruitment, refusal and randomisation rates of older adults into a general practice-based clinical trial with two versions (varied format, content and language) of the Participant Information and Consent Form (PICF). METHODS: This prospective PICF study was conducted within the STAREE (STAtins in Reducing Events in the Elderly) clinical trial. Participants phone screened between October 2015 to February 2016 formed Group 1 and were mailed the extended PICF version and participants phone screened between October 2016 to February 2017 formed Group 2 and were mailed the shortened PICF version. Participants who attended a subsequent baseline screening visit were guided through a comprehensive informed consent process. RESULTS: During the screening phase of the trial, the likelihood of refusing trial participation was lower in Group 2 compared to Group 1 equating to an overall 23% reduction in risk (RR 0.77, P = 0.005, 95% CI 0.62-0.95). Group 2 had a 6.4% higher randomisation rate compared with Group 1 (65.3% versus 58.9% respectively) but this difference was not statistically significant. Factors associated with trial participation were male gender, age between 70 and 75 years and living alone (all p < .0.05). CONCLUSIONS: Whilst avoiding lengthy and complex PICF documents may assist with initial trial engagement, it needs to be supplemented with other strategies to support ongoing trial interest to randomisation and beyond. Participants refused trial participation throughout the screening phase indicating that the PICF was only one factor among several affecting an individual's decision to participate in this clinical trial.