The proposed EAGER research project will lead to obtaining the preliminary data needed to establish that a correlation exists between the physical environment in contact with eyes during non-supine sleep and sustained periods of elevated intraocular pressure (IOP) during non-supine sleep. The hypothesis to be tested by this research is that a traditional sleep environment, i.e. resting on a conventional mattress and pillow, places the eyes of non-supine sleepers in a physical environment that leads to an elevation in IOP. To test this hypothesis, study subjects, half with healthy eyes and half with asymmetric glaucoma damage, will be fitted with two Sensimed Triggerfish® wireless, contact-lens-based strain sensors (one in each eye). These sensors will be used to record changes in IOP throughout the night. The studies will be conducted at the Johns Hopkins Sleep Center to simultaneously record video of sleep positions. IOP and position data will be used to correlate eye contact with the physical environment to changes in IOP as well as to establish potential differences in the sensitivity of subjects with and without glaucoma to variations in physical environment properties. The technical merit of establishing the hypothesized correlation lies in advancing the understanding of a here-to-fore overlooked factor that contributes to the elevation of IOP. The significance of is that IOP elevation is primary risk factor associated with eye damage and vision loss in individuals with glaucoma. (Glaucoma is the second leading cause of blindness worldwide and affects an estimated 60 million people globally at this time; a number is expected to increase to 80 million by 2020) The impact of validating this hypothesis is that understanding that the sleep environment contributes to the primary risk factor for disease progression will lead to developing strategies to fix or alter the environment.
The exploratory nature of the proposed research, i.e. that funding is needed to obtain preliminary results that substantiate the proposed hypothesis, is the reason the proposed research does not fit well within the existing programmatic opportunities. The justification for seeking support for this research through the EAGER mechanism is that the proposed research is high risk, exploratory, and potentially transformative. The research is high risk in that conventional wisdom suggests that the result will be negative. After almost 400 years of study related to different aspects of this disease, how is it that this macro-scale concern has been neglected? Vision experts readily provide the following as the justification for the current practice of ignoring loads from the sleep environment as a risk factor for glaucoma patients: the pre-operative application of compressive loads to the eye is routinely used to increase aqueous outflow and thereby lower IOP. This argument, however, neglects the potential importance of differences in the eye environment during load application; the importance of these differences is precisely what we aim to discover with the proposed research. Next, the proposed research is exploratory in that this will be the first quantitative study of the interaction of environment to which the eye is exposed during non-supine sleep with IOP. The ability to obtain preliminary result to address this research is greatly facilitated by of the advent in 2011 of Sensimed's Triggerfish® wireless contact-lens-based strain sensors.
Finally, if/when the research hypothesis is demonstrated to be correct, the broader impact of the research on those with glaucoma-related visual impairment will be transformational. The impact on altering conventional wisdom, which completely neglects sleep environment as a risk factor for those with glaucoma, will be immediate. Further research will be necessary to address how to most effectively alter sleep environments to mitigate IOP elevation. Results from the proposed EAGER research will provide the preliminary results needed to raise awareness of that sleep environment can pose a significant risk for glaucoma patients who are non-supine sleepers, and that modifications to a sleep environment can be used to slow the progressive loss to field of vision experienced by these individuals.
