[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07298356":3,"trial-entities:NCT07298356":105,"trial-summary:NCT07298356":109},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":47,"secondary_outcomes":60,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":75,"locations":78,"central_contacts":96,"overall_officials":101,"references":103,"see_also_links":104},"NCT07298356","Pro00106111_1","Automated Applanation Tonometry - Updated","RECRUITING","2026-12-29","2025-12","2026-03-06","2026-03-02","Duke University","OTHER",true,"Goldmann Applanation Tonometry (GAT) is considered the clinical gold standard for eye pressure measurements and yet it is known to be a subjective measurement with limited repeatability and limited portability. Another clinical standard for checking eye pressure is known as the pneumotonometer. This method is more objective but not portable. The purpose of this study is to develop new methods of measuring eye pressure that are more objective, reproducible and portable. In this study, the investigators will be comparing the eye pressure measurements using 2 investigational methods to GAT and pneuumotonometer.","This is a prospective study. Patients presenting for their scheduled eye appointments will be recruited by verbal communication. Following informed consent, intraocular pressure (IOP) measurements will be made by the following methods:\n\nStandard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice. The eye is given topical fluorescein\u002Fanesthetic, the GAT prism contacts the eye while the observer looks through the slit lamp machine ocular using blue light illumination to visual the applanation mires. The GAT dial is adjusted until mire alignment is achieved and the IOP measurement is read off the GAT dial.\n\nPneumotonometer: This is what is done in routine eye care. The participant will receive a topical anesthetic (numbing agent). A probe will touch the front of the eye while the machine measures the eye pressure.\n\nFixed force GAT: From the patient perspective, this method will feel identical to the standard GAT. The eye is given topical fluorescein\u002Fanesthetic. The GAT dial is set at 1.8 or 2.0, a complementary metal oxide semiconductor (C-MOS) camera is connected to one of the oculars of the slit lamp machine and under blue light illumination, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance through the ocular. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter. A similar method using an iPod touch camera has been previously published by this PI.\n\nUpright applanating prototype: With this prototype, an applanating prism (custom manufactured with medical grade acrylic in an ISO-13485 certified facility) is attached to a fixed-force spring that creates a force equivalent to 1.8 or 2.0 on the GAT dial. Blue LED lights on the prototype are used to create the blue illumination similar to the blue light used in clinical practice on the slit lamp or Perkins tonometer. A C-MOS camera is aligned with the GAT prism to image the applanation mires. The eye is given topical fluorescein\u002Fanesthetic. Like fixed-force GAT, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter.\n\nThe order of the above 4 measurements will be randomized.",[18,19],"Glaucoma","Glaucoma, Suspect",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},200,"ESTIMATED",[29,34,39,43],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Standard GAT","Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Fixed force GAT","An investigational device similar to standard GAT",[38],"Fixed-force GAT",{"type":30,"name":40,"description":41,"armGroupLabels":42},"Upright applanating prototype","An investigational device, prism used in standard and fixed-force GAT is attached to a portable device",[40],{"type":30,"name":44,"description":45,"armGroupLabels":46},"Pneumotonometer","This is a standard for checking eye pressure. A topical anesthetic (numbing agent). A probe will touch the front of the eye while the machine measures the eye pressure",[44],[48,52,55,58],{"measure":49,"description":50,"timeFrame":51},"Intraocular pressure (IOP) as measured by standard GAT","this is the standard method for IOP measurement in clinical practice. The eye is given topical fluorescein\u002Fanesthetic, the GAT prism contacts the eye while the observer looks through the slit lamp machine ocular using blue light illumination to visual the applanation mires. The GAT dial is adjusted until mire alignment is achieved and the IOP measurement is read off the GAT dial.","Baseline",{"measure":53,"description":54,"timeFrame":51},"Intraocular pressure (IOP) as measured by fixed force GAT","From the patient perspective, this method will feel identical to the standard GAT. The eye is given topical fluorescein\u002Fanesthetic. The GAT dial is set at 1.8 or 2.0, a C-MOS camera is connected to one of the oculars of the slit lamp machine and under blue light illumination, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance through the ocular.",{"measure":56,"description":57,"timeFrame":51},"Intraocular pressure as measured by upright applanating","With this prototype, an applanating prism (custom manufactured with medical grade acrylic in an ISO-13485 certified facility) is attached to a fixed-force spring that creates a force equivalent to 1.8 or 2.0 on the GAT dial. Blue LED lights on the prototype are used to create the blue illumination similar to the blue light used in clinical practice on the slit lamp or Perkins tonometer. A C-MOS camera is aligned with the GAT prism to image the applanation mires. The eye is given topical fluorescein\u002Fanesthetic. Like fixed-force GAT, the GAT prism contacts the eye while the CMOS camera makes a video of the mire appearance. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter.",{"measure":59,"timeFrame":51},"Intraocular pressure as measured by supine Pneumotonometer",[],"ALL","18 Years",null,false,{"inclusion":66,"exclusion":70,"raw_text":74},[67,68,69],"Presenting for a routine eye exam","≥ 18 years of age","Able and willing to give consent",[71,72,73],"History of corneal scarring","Active infection of the eye","Ocular surface trauma or infection","Criteria:\n\nInclusion Criteria:\n\n* Presenting for a routine eye exam\n* ≥ 18 years of age\n* Able and willing to give consent\n\nExclusion Criteria:\n\n* History of corneal scarring\n* Active infection of the eye\n* Ocular surface trauma or infection",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"status":7,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":93},"Duke Eye Center","Durham","North Carolina","27710","United States",[86,91],{"name":87,"role":88,"phone":89,"email":90},"Joanne Wen, MD","CONTACT","919-684-2975","joanne.wen@duke.edu",{"name":87,"role":92},"PRINCIPAL_INVESTIGATOR",{"lat":94,"lon":95},35.99403,-78.89862,[97],{"name":98,"role":88,"phone":99,"email":100},"Sarah Jones","919 681 6584","sarah.jones1@duke.edu",[102],{"name":87,"affiliation":80,"role":92},[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[18,107],"Glaucoma suspect",[],{"nct_id":4,"found":14,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study planning to enroll 200 participants. It is a prospective study, meaning participants are recruited as they come in for eye appointments.","completed","Automated Applanation Tonometry for Glaucoma","This study is comparing new ways to measure eye pressure (intraocular pressure or IOP) to the standard methods. Eye pressure is important for conditions like glaucoma and glaucoma suspect. Researchers are testing two new devices: a \"Fixed force GAT\" and an \"Upright applanating prototype.\" These will be compared to the standard Goldmann Applanation Tonometry (GAT) and a Pneumotonometer, which are common ways to check eye pressure. The goal is to find more accurate, consistent, and portable ways to measure IOP. You may be able to join if you are 18 or older, coming in for a routine eye exam, and do not have certain eye conditions like corneal scarring or active eye infections. The study aims to enroll 200 participants, but its current status is unclear.","Eye pressure measurements are taken at baseline (at the start of your participation).",126,"You will have your eye pressure measured using four different methods: Standard GAT, Fixed force GAT, Upright applanating prototype, and Pneumotonometer. Some methods involve a numbing agent and a probe touching your eye.","Not stated in the trial record.",[35,40,44],"v2"]