[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07149259":3,"trial-entities:NCT07149259":102,"trial-summary:NCT07149259":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":42,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":14,"eligibility_criteria":49,"std_ages":73,"locations":76,"central_contacts":94,"overall_officials":97,"references":100,"see_also_links":101},"NCT07149259","PRO00085670","Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment","RECRUITING","2026-06-01","2025-08","2025-08-29","2025-06-18","Brooks Rehabilitation","OTHER",false,"This research aims to test the updated version of Gentex's device, eSight Go, an image enhancing wearable device to assist those with vision impairments limiting activities of daily living.","Subjects will receive introductory training on the controls of the study device at the initial study visit and regular follow-up phone calls once per week from a member of the research staff (e.g., an occupational therapist, or low vision therapist) who is familiar with the study device, to assist with possible troubleshooting as well as device use strategies. You will take the study device home for four weeks to use at school, work, and various daily activities.",[18],"Low Vision Aids",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},50,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","At Home Use","Participants will take the device home for 4 weeks to use in daily living, such as the home and community settings. There will be regular follow-up phone calls once per week from a member of the research team (e.g., an occupational therapist, or low vision therapist) who is familiar with the device to assist with possible troubleshooting as well as device use strategies. The follow up calls will also collect information about device use time and activities. The device will be returned at visit 2.",[33],"At Home Device Utilization",[35,39],{"measure":36,"description":37,"timeFrame":38},"Change in Visual Acuity","Early Treatment Diabetic Retinopathy Study Chart (ETDRS) assessing visual acuity. A lower logMAR value indicates an improved score.","Pre-intervention and post-intervention at 4 weeks",{"measure":40,"description":41,"timeFrame":38},"Change in Reading Performance","Minnesota Low Vision Reading Test assessing reading performance. A lower logMAR value indicates an improved score.",[43],{"measure":44,"description":45,"timeFrame":38},"Change in Mobility","Dynamic Gait Index (DGI) assessing the ability of the participant to maintain walking balance. 8 items are scored on a scale of 0 to 4, where 0=severe impairment, 1=moderate impairment, 2=mild impairment, and 3=normal. An increase in score reflects an improvement in mobility.","ALL","18 Years","90 Years",{"inclusion":50,"exclusion":61,"raw_text":72},[51,52,53,54,55,56,57,58,59,60],"Aged 18 to 90.","Best-corrected visual acuity between 20\u002F50 to 20\u002F400 in the better eye.","Subjects who have been diagnosed with an ocular condition causing visual impairment","Have a functional binocular field of view of at least 20 degrees.","Visual status stable for at least six months.","Demonstrate visual benefit from magnification.","Agree to wear the eSight Go in a variety of situations in the home and community.","Score ≥ 20 on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (OMCT).","Subject must be able to provide an informed consent","Subject must agree to use eSight Eyewear only under conditions that will not jeopardize the safety of either the user or the device.",[62,63,64,65,66,67,68,69,70,71],"Participant must not be currently undergoing any medical or surgical procedures resulting in unstable vision.","Participants who have undergone cataract, refractive, or other surgical procedures related to vision in the six-month period prior to study enrollment.","Severe (\\>20\u002F400) visual impairment in the better seeing eye.","Cognitive limitations (\\\u003C 20 on OMCT).","Participants who have undergone any vision-related injections (e.g. anti-VEGF) in the two-month period prior to the study because of active bleeding in the retina. Ongoing anti-VEGF treatments are permitted if the participant is in a \"Treat and Extend\" or pro re nata (\"PRN\") disease management, and macula is dry.","Participants are unable or unwilling to adhere to the examination schedules as they are described in the study protocol. This may also include participants already enrolled, who for whatever reason, have become unable or unwilling to continue the study. This may also include participants for whom the travel time to\u002Ffrom the study site is unacceptable.","Participants who self-report a history of alcoholism, drug abuse, or psychosis.","Participants who exhibit clinical evidence of depression, poor motivation, emotional or intellectual problems, or any other conditions which would likely limit validity of consent or appropriate responses to participate in the study or who are deemed unsuitable psychologically or physiologically for study participation by the investigator.","Participants who may have a conflict of interest with eSight Corp, which could reasonably influence their participation in the study.","Refractive error outside the range correctable by lens inserts in the device (\\> +\u002F-8.00 D sph or -4.00 cyl)","Inclusion Criteria:\n\n* Aged 18 to 90.\n* Best-corrected visual acuity between 20\u002F50 to 20\u002F400 in the better eye.\n* Subjects who have been diagnosed with an ocular condition causing visual impairment\n* Have a functional binocular field of view of at least 20 degrees.\n* Visual status stable for at least six months.\n* Demonstrate visual benefit from magnification.\n* Agree to wear the eSight Go in a variety of situations in the home and community.\n* Score ≥ 20 on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (OMCT).\n* Subject must be able to provide an informed consent\n* Subject must agree to use eSight Eyewear only under conditions that will not jeopardize the safety of either the user or the device.\n\nExclusion Criteria:\n\n* Participant must not be currently undergoing any medical or surgical procedures resulting in unstable vision.\n* Participants who have undergone cataract, refractive, or other surgical procedures related to vision in the six-month period prior to study enrollment.\n* Severe (\\>20\u002F400) visual impairment in the better seeing eye.\n* Cognitive limitations (\\\u003C 20 on OMCT).\n* Participants who have undergone any vision-related injections (e.g. anti-VEGF) in the two-month period prior to the study because of active bleeding in the retina. Ongoing anti-VEGF treatments are permitted if the participant is in a \"Treat and Extend\" or pro re nata (\"PRN\") disease management, and macula is dry.\n* Participants are unable or unwilling to adhere to the examination schedules as they are described in the study protocol. This may also include participants already enrolled, who for whatever reason, have become unable or unwilling to continue the study. This may also include participants for whom the travel time to\u002Ffrom the study site is unacceptable.\n* Participants who self-report a history of alcoholism, drug abuse, or psychosis.\n* Participants who exhibit clinical evidence of depression, poor motivation, emotional or intellectual problems, or any other conditions which would likely limit validity of consent or appropriate responses to participate in the study or who are deemed unsuitable psychologically or physiologically for study participation by the investigator.\n* Participants who may have a conflict of interest with eSight Corp, which could reasonably influence their participation in the study.\n* Refractive error outside the range correctable by lens inserts in the device (\\> +\u002F-8.00 D sph or -4.00 cyl)",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":12,"status":7,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":91},"Jacksonville","Florida","32216","United States",[83,88],{"name":84,"role":85,"phone":86,"email":87},"Hannah Grimes","CONTACT","904-528-3159","hannah.grimes@brooksrehab.org",{"name":89,"role":90},"Katelyn Jordan","PRINCIPAL_INVESTIGATOR",{"lat":92,"lon":93},30.33218,-81.65565,[95],{"name":84,"role":85,"phone":96,"email":87},"904-597-3478",[98],{"name":99,"affiliation":12,"role":90},"Katelyn Jordan, D.O.",[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Low Vision",[],{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an interventional study, meaning participants will receive a specific device to use. It plans to enroll about 50 participants.","completed","eSight Go At-Home Usage for Visual Impairment","This study is testing an updated version of a wearable device called eSight Go. This device helps people with vision impairment by enhancing images to make daily activities easier. You might be able to join if you are 18 to 90 years old, have vision between 20\u002F50 and 20\u002F400 in your better eye due to an eye condition, and your vision has been stable for at least six months. The study will look at whether using eSight Go improves your visual sharpness (visual acuity) and your ability to read. The study is currently unclear on its recruitment status and plans to enroll about 50 people.","Your visual acuity and reading performance will be measured again after four weeks of using the device.",105,"You will receive training on the eSight Go device and then take it home for four weeks to use in your daily life. A research team member will call you weekly to help with troubleshooting and device use strategies.","Not stated in the trial record.",[],"v2"]