After centuries of physicians believing that they know what is best for patients, this paternalistic approach to patient care is being challenged. The explosion in readily accessible information has resulted in patients being empowered to take on a greater role in decision making, from clinical care to regulatory decision making. The Centers of Excellence in Regulatory Science and Innovation (CERSIs) are collaborating with the US Food and Drug Administration (FDA) to promote patient engagement and advance patient preference research.

Background

Many therapeutic options are available to glaucoma patients. One recent therapeutic option is minimally invasive glaucoma surgical (MIGS) devices. It is unclear how patients view different treatments and which patient-reported outcomes would be most relevant in patients with mild to moderate glaucoma. We developed a questionnaire for patients eligible for MIGS devices and a patient preference study to examine the value patients place on certain outcomes associated with glaucoma and its therapies.

Objectives

To summarize the progress to date.

Methods

Questionnaire development: We drafted the questionnaire items based on input from one physician and four patient focus groups, and a review of the literature. We tested item clarity with six cognitive interviews. These items were further refined. Patient preference study: We identified important benefit and risk outcomes qualitatively using semi-structured, one-on-one interviews with patients who were eligible for MIGS devices. We then prioritized these outcomes quantitatively using best-worst scaling methods.

Results

Questionnaire testing: Three concepts were deemed relevant for the questionnaire: functional limitations, symptoms, and psychosocial factors. We will evaluate the reliability and validity of the 52-item draft questionnaire in an upcoming field test. Patient preference study: We identified 13 outcomes that participants perceived as important. Outcomes with the largest relative importance weights were "adequate IOP control" and "drive a car during the day."

Conclusions

Patients have the potential to steer clinical research towards outcomes that are important to them. Incorporating patients' perspectives into the MIGS device development and evaluation process may expedite innovation and availability of these devices.

Objective

To investigate the association between African admixture and glaucoma prevalence among African American women.

Design, setting, participants

Participants included 11616 African American women from the Women's Health Initiative Study (WHI) for whom admixture information was available and included 2548 who self-reported a diagnosis of glaucoma.

Main outcome measures

Glaucoma.

Results

Significant association was observed between self-identified glaucoma status and admixture. However, this association was not significant in a model that included neighborhood socioeconomic status (NSES), hypertension, diabetes and body mass index (BMI). Self-identified glaucoma status was associated with diabetes that persisted after adjustment for admixture, NSES, hypertension, and BMI. Lower NSES was also associated with higher glaucoma risk but this association was marginal in the fully adjusted model and neither hypertension nor BMI showed association. When glaucoma status was limited to those reporting use or no use of appropriate ophthalmologic medication, no associations were observed in any of the models.

Conclusion

This study failed to find an independent association of glaucoma status and African admixture and these findings suggest that the higher frequency glaucoma in African Americans may be largely due to other factors.

OBJECTIVE: To investigate the association between African admixture and glaucoma prevalence among African American women. DESIGN, SETTING, PARTICIPANTS: Participants included 11616 African American women from the Womens Health Initiative Study (WHI) for whom admixture information was available and included 2548 who self-reported a diagnosis of glaucoma. MAIN OUTCOME MEASURES: Glaucoma. RESULTS: Significant association was observed between self-identified glaucoma status and admixture. However, this association was not significant in a model that included neighborhood socioeconomic status (NSES), hypertension, diabetes and body mass index (BMI). Self-identified glaucoma status was associated with diabetes that persisted after adjustment for admixture, NSES, hypertension, and BMI. Lower NSES was also associated with higher glaucoma risk but this association was marginal in the fully adjusted model and neither hypertension nor BMI showed association. When glaucoma status was limited to those reporting use or no use of appropriate ophthalmologic medication, no associations were observed in any of the models. CONCLUSION: This study failed to find an independent association of glaucoma status and African admixture and these findings suggest that the higher frequency glaucoma in African Americans may be largely due to other factors.

PURPOSE: To investigate the association between oral contraceptive (OC) use and glaucoma prevalence in the United States. DESIGN: Cross-sectional study. PARTICIPANTS: A total of 3406 female participants, aged 40 years or older, from the 2005 to 2008 National Health and Nutrition Examination Survey, who reported a presence or absence of glaucoma or ocular hypertension completed both the vision and the reproductive health questionnaires and underwent eye examinations. METHODS: Multivariate regression analysis was used to assess the correlation between OC use and self-reported glaucoma or ocular hypertension (n = 231 cases), controlling for potential confounders, including age, ethnicity, systemic comorbidities such as hypertension and stroke, ocular diseases such as cataract and diabetic retinopathy, and reproductive health factors, including age at menopause, age at menarche, history of hormone replacement therapy, and gynecological surgical history. MAIN OUTCOME MEASURES: The outcome variable was self-reported glaucoma or ocular hypertension. RESULTS: After adjusting for confounders, those with ≥3 years of OC use had greater odds (odds ratio, 1.94; 95% confidence interval, 1.22-3.07) of self-reported glaucoma or ocular hypertension. Other factors associated with higher glaucoma or ocular hypertension prevalence included older age, African American race, and later age at menarche. CONCLUSIONS: Oral contraceptive use may be associated with increased risk of self-reported glaucoma or ocular hypertension.

Purpose

To determine factors that influence patient satisfaction scores in individuals who have recently had cataract surgery.

Setting

Byers Eye Institute, Palo Alto, California, USA.

Design

Prospective case series.

Methods

Selected questions from the Press Ganey survey and the National Eye Institute Visual Function Questionnaire-25 were administered to each patient immediately after completion of a clinic visit. The correlation between patient-specific variables and the answer to the survey question "likelihood of recommending our practice to others," a surrogate for overall patient satisfaction, was assessed using the Student t test. A logistical regression model was used to adjust for potentially confounding variables.

Results

One hundred forty-three patients were recruited from 4 providers; 57 (39.8%) were men, and the mean age was 70.0 years ± 11.6 (SD). The main outcome was the proportion of scores less than 5, or "very good," for the likelihood of recommending the practice to others. There was a statistically significant association between a non-5 patient satisfaction score and self-reported ethnicity of Asian or Pacific Islander compared with other ethnicities (odds ratio [OR], 2.3; 95% confidence interval [CI], 1.0-5.1; P = .049); other possible correlates were not statistically significant. The relationship persisted after adjustment for potential confounding variables (OR, 2.6; 95% CI, 1.1-6.3; P = .027).

Conclusion

In postoperative cataract patients, Asian or Pacific Islander ethnicity, a factor out of the control of the provider and clinic staff, was associated with a lower overall Press Ganey patient satisfaction score compared with patients of all other ethnicities.

Purpose

To develop a vision-targeted health-related quality-of-life instrument for patients with glaucoma who are candidates for minimally invasive glaucoma surgery (MIGS).

Design

Development of a health-related quality-of-life instrument.

Participants

Twelve practicing ophthalmologists and 41 glaucoma patients.

Methods

A questionnaire was constructed to assess functional limitations, vision-related symptoms, aesthetics, psychosocial issues, and surgical satisfaction for MIGS candidates. Questions were drafted after a review of the literature and subsequently refined based upon input from 1 physician and 4 patient focus groups. Nineteen cognitive interviews were used to ensure that questions were understandable to respondents.

Results

The focus group identified the following key issues and concerns as being important to glaucoma patients: functional limitations (eg, driving), bodily discomfort (eg, stinging from drops), changes in appearance (eg, drooping eyelid), and psychosocial concerns (eg, mental burden associated with a diagnosis of glaucoma, financial burden of treatment). Cognitive interviews resulted in the following improvements to the questionnaire: changes in wording to clarify lighting conditions, and additional questions addressing psychosocial issues, such as job loss, severity of disease, and perception of MIGS.

Conclusions

A patient-reported outcomes instrument, the Glaucoma Outcomes Survey, was developed to evaluate MIGS for patients with mild to moderate glaucoma. Next steps include electronic administration to patients selected from the American Academy of Ophthalmology Intelligent Research in Sight (IRIS) registry. An electronic patient-reported outcomes platform will be used to administer the questionnaire before and after MIGS. The questionnaire will improve understanding of how surgical interventions such as MIGS impact vision-targeted health-related quality-of-life in glaucoma patients.

Differences in patient characteristics between the PTVT and TVT Studies, including the level of preoperative intraocular pressure, contributed to the differences in surgical failure rates in each trial.

Purpose

To determine factors impacting cumulative dissipated energy (CDE) and postoperative best-corrected visual acuity (BCVA) in phacoemulsification.

Design

Review of 1102 cases at University of California, San Francisco (UCSF) and at Zhongshan Ophthalmic Center (ZOC), China.

Subjects

Patients who underwent cataract surgery at UCSF 03/2014-03/2019 and at ZOC 10/2018-05/2019.

Methods

Patient demographics, medical history, routine ocular examination, and surgical information, including disassembly method, complications, and surgeon training level were recorded. Univariable and multivariable regression models were used to determine factors associated with CDE and good postoperative BCVA (20/40 or better) at 1 month.

Outcome measures

CDE, postoperative BCVA.

Results

In multivariable analysis, patient age at time of surgery, diabetes, degree of nuclear sclerosis (NS), white-to-white corneal diameter, disassembly method, preoperative BCVA, surgeon training level, and surgical center were significantly associated with CDE. Log₁₀CDE increased by 0.20-0.31 for patient age ≥ 70 years, by 0.07 if the patient had diabetes, by 0.12-0.41 for NS grade ≥ 2, by 0.48 per 10 mm increase in white-to-white corneal diameter, by 0.34-0.47 for disassembly method other than non-stop chop, by 0.16 per unit increase in preoperative logMAR BCVA, and by > 0.09 when phacoemulsification was performed by residents early in their training. Log₁₀CDE was 0.33 higher at UCSF than ZOC. In multivariable analysis, worse baseline visual acuity and age above 90 years at time of surgery decreased the odds of good BCVA (OR = 0.26 per unit increase in preoperative logMAR BCVA; OR = 0.12 for age > 90); comorbid retinal issues decreased the odds of good postoperative BCVA (OR = 0.13-0.39); greater anterior chamber depth (ACD) or shorter axial length (AL), increased the odds of good postoperative outcome (OR = 2.64 per 1 mm increase ACD, OR = 0.84 per 1 mm increase AL).

Conclusions

Cataract grade determined by slit lamp exam and, for the first time, older patient age, were noted to be important predictors of high CDE. CDE was not a risk factor for postoperative BCVA measured at postoperative 1 month. When surgery was performed by trainees under supervision, lower training level was associated with higher CDE, but not with worse postoperative BCVA.

Aim

To assess the efficacy and safety of latanoprostene bunod (LBN) compared with latanoprost 0.005%, and to determine the optimum drug concentration(s) of LBN in reducing intraocular pressure (IOP) in subjects with open angle glaucoma or ocular hypertension.

Methods

Randomised, investigator-masked, parallel-group, dose-ranging study. Subjects instilled one drop of study medication in the study eye once daily each evening for 28 days and completed five study visits. The primary efficacy endpoint was the reduction in mean diurnal IOP at Day 28.

Results

Of the 413 subjects randomised (LBN 0.006%, n=82; LBN 0.012%, n=85; LBN 0.024%, n=83; LBN 0.040%, n=81; latanoprost, n=82), 396 subjects completed the study. Efficacy for LBN was dose-dependent reaching a plateau at 0.024%-0.040%. LBN 0.024% led to significantly greater reductions in diurnal IOP compared with latanoprost at the primary endpoint, Day 28 (p=0.005), as well as Days 7 (p=0.033) and 14 (p=0.015). The incidence of adverse events, mostly mild and transient, was numerically higher in the LBN treatment groups compared with the latanoprost group. Hyperaemia was similar across treatments.

Conclusions

LBN 0.024% dosed once daily was the lower of the two most effective concentrations evaluated, with significantly greater IOP lowering and comparable side effects relative to latanoprost 0.005%. LBN dosed once daily for 28 days was well tolerated.

Clinical trial number

NCT01223378.