Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT07298356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Automated Applanation Tonometry - Updated
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this 2 investigational methods (Fixed-force GAT and handheld tonometer) will be compared to the 2 standard methods (Standard GAT and pneumotonometer).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure (IOP) as measured by standard GAT', 'timeFrame': 'Baseline', 'description': 'this is the standard method for IOP measurement in clinical practice. The eye is given topical fluorescein/anesthetic, 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.'}, {'measure': 'Intraocular pressure (IOP) as measured by fixed force GAT', 'timeFrame': 'Baseline', 'description': 'From the patient perspective, this method will feel identical to the standard GAT. The eye is given topical fluorescein/anesthetic. 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': 'Intraocular pressure as measured by upright applanating', 'timeFrame': 'Baseline', 'description': '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/anesthetic. 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': 'Intraocular pressure as measured by supine Pneumotonometer', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Glaucoma', 'Glaucoma, Suspect']}, 'descriptionModule': {'briefSummary': '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, we will be comparing the eye pressure measurements using 2 investigational methods to GAT and pneuumotonometer.', 'detailedDescription': '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/anesthetic, 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. You 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/anesthetic. 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/anesthetic. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07298356', 'briefTitle': 'Automated Applanation Tonometry - Updated', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Automated Applanation Tonometry - Updated', 'orgStudyIdInfo': {'id': 'Pro00106111_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard GAT', 'description': 'This is the gold-standard method for IOP measurement in clinical practice', 'interventionNames': ['Device: Standard GAT']}, {'type': 'EXPERIMENTAL', 'label': 'Fixed-force GAT', 'description': 'From the patient perspective, this method will feel identical to the standard GAT. The eye is given topical fluorescein/anesthetic. 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. The diameters of the recorded mire images are measured and the IOP is calculated based on the mire diameter', 'interventionNames': ['Device: Fixed force GAT']}, {'type': 'EXPERIMENTAL', 'label': 'Upright applanating prototype', 'description': '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/anesthetic. 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', 'interventionNames': ['Device: Upright applanating prototype']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pneumotonometer', 'description': 'This is another standard method for IOP measurement in clinical practice', 'interventionNames': ['Device: Pneumotonometer']}], 'interventions': [{'name': 'Standard GAT', 'type': 'DEVICE', 'description': 'Standard Goldmann Applanation Tonometry (GAT): this is the standard method for IOP measurement in clinical practice', 'armGroupLabels': ['Standard GAT']}, {'name': 'Fixed force GAT', 'type': 'DEVICE', 'description': 'An investigational device similar to standard GAT', 'armGroupLabels': ['Fixed-force GAT']}, {'name': 'Upright applanating prototype', 'type': 'DEVICE', 'description': 'An investigational device, prism used in standard and fixed-force GAT is attached to a portable device', 'armGroupLabels': ['Upright applanating prototype']}, {'name': 'Pneumotonometer', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['Pneumotonometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Joanne Wen, MD', 'role': 'CONTACT', 'email': 'joanne.wen@duke.edu', 'phone': '919-684-2975'}, {'name': 'Joanne Wen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Sarah Jones', 'role': 'CONTACT', 'email': 'sarah.jones1@duke.edu', 'phone': '919 681 6584'}], 'overallOfficials': [{'name': 'Joanne Wen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No Currently, there is no plan to share data with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}