Health Condition 1: H400- Glaucoma suspect
Conditions
Interventions
Intervention1: Over the Eyelid Tonometry OET Accuway: in measuring Intraocular Pressure
Control Intervention1: Goldmann
Applanation Tonometry (GAT): The Goldmann applanation tonometer (GAT) is curren
Sponsors
OKO iCare Solutions pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: Normal IOP: 1. Male or Female: Age = 18 years Male or Female 2. Healthy volunteers with no history of corneal disease, ocular hypertension, or glaucoma age and gender match control, non Glaucoma cases. 3. Participants having =10 mmHg IOP also included. 4. Willing and able to provide informed consent for participation in the study. 5. Ability to undergo intraocular pressure (IOP) measurements using Air puff tonometry, over-the eyelid tonometry, and Goldmann tonometry Abnormal IOP: 1. Male or Female: Age = 18 years 2. Suspected or recently diagnosed Glaucoma cases. 3. Participants having =10 mmHg IOP also included. 4. Willing and able to provide informed consent for participation in the study. 5. Ability to undergo intraocular pressure (IOP) measurements using Air puff tonometry, over-the eyelid tonometry, and Goldmann tonometry
Exclusion criteria
Exclusion criteria: 1. Participants under the age of 18. 2. Inability to provide informed consent 3. Known contraindications to any of the tonometry techniques (Air puff tonometry, over-the-eyelid tonometry, Goldmann tonometry), have significant corneal abnormalities, acute eye infections or have a history of ocular surgery within the past 6 months. 4. Chronic conjunctivitis, cornea pathology, including keratitis, keratotomy, cornea dimness, after penetrating keratoplasty, keratoprosthesis, high degree of ametropia, astigmatism, Edema, Injury to the eyelid, upper lid pathology (inflammatory diseases, scars, eyelid deformation). 5. Expressed sclera and/or conjunctiva pathology in the measuring area, Viral infections, allergic reactions, dry eye syndrome, Post corneal surgery, laser refractive correction of the eyesight. 6. Significant corneal abnormalities and acute eye infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of IOP measurements as determined by the mean difference between the novel over-the-eyelid tonometry device and the GAT and APT devicesTimepoint: At Baseline Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Intra-device & inter-device variability in IOP measurements. Patient comfort & preference for the different tonometry methods. Incidence of adverse events associated with each tonometry method. Safety & tolerability of the over-the-eyelid tonometry device as assessed by the presence of any adverse events or participant-reported discomfort. User acceptability of the over-the-eyelid tonometry device as determined by participant satisfaction & ease of use. Timepoint: At Baseline Visit | — |
Countries
India
Contacts
Public ContactNeha Lande
OKO iCare Solutions pvt ltd
Outcome results
None listed