None listed
Conditions
Interventions
Medical Device : The HNT-1/P measures the intraocular pressure three times and checks the central corona thickness of the eye.
For the safety evaluation the compared equipment should measure the intra
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [i.120 eyes except advanced corneal astigmatism] 1. 19 =age= 80 2. 7 =IOP< 60 mmHg 3. 500 =CCT< 600 µm 4. subject with functional eyes 5. A person who voluntarily agree to participate and agreed in writing to consent form. 6. Those who can understand and follow the instructions and participate in the entire period of the clinical trial. [ ii. 30eyes advanced corneal astigmatism] 1. 19 =age= 80 2. 7 =IOP< 60 mmHg 3. 500 =CCT< 600 µm 4. subject with functional eyes 5. A person who voluntarily agree to participate and agreed in writing to consent form. 6. Those who can understand and follow the instructions and participate in the entire period of the clinical trial. 7. Corneal astigmatism exceeding 3 Diopter
Exclusion criteria
Exclusion criteria: [i.120 eyes except advanced corneal astigmatism] 1. those with one eye having eccentric fixation 2. At least one of the following: -advanced corneal astigmatism -those with corneal scarring or who have had corneal surgery including corneal laser surgery -microphthalmos -buphthalmos -dry eye (except ; In case there is no present symptom at screening time, despite history of dry eye.) -lid squeezers, blepharospasm -nystagmus -keratoconus -any other corneal or conjunctival pathology of infection 3. Wearing contact lenses Within 2 weeks of screening time 4. Known hypersensitivity to local anesthetic (ex; proparacaine hydrochloride) and Fluorescent pigment (ex; fluorescein) 5. Person who participates in other interventional clinical trials within a period of one month 6. Pregnant, breast-feeding, possibly pregnant women 7. Ineligible for participating in this study according to the investigator or sub-investigator. [ ii. 30eyes advanced corneal astigmatism] 1. those with one eye having eccentric fixation 2. At least one of the following: -those with corneal scarring or who have had corneal surgery including corneal laser surgery -microphthalmos -buphthalmos -dry eye (except ; In case there is no present symptom at screening time, despite history of dry eye -lid squeezers, blepharospasm -nystagmus -keratoconus -any other corneal or conjunctival pathology of infection 3. Wearing contact lenses Within 2 weeks of screening time 4. Known hypersensitivity to local anesthetic (ex; proparacaine hydrochloride) and Fluorescent pigment (ex; fluorescein) 5. Person who participates in other interventional clinical trials within a period of one month 6. Pregnant, breast-feeding, possibly pregnant women 7. Ineligible for participating in this study according to the investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| confirm the clinical usefulness by analyzing correlation between both three times average measurements of the the Goldmann applanation tonometer and the HNT-1/P | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency (%) of the difference between the HNT-1/P and the Goldmann applanation tonometer value exceeds ± 5 mmHg for the mean pressure;Determination of statistical significance and correlation about the difference between the central angle thickness measured during screening (or measurement results within 6 months) and the central angle thickness measured by HNT-1/P ;Comparison of IOP Compensated Intractor Pressure (CIOP) considering the center thickness of HNT-1P with IOP of the Goldmann applanation tonometer | — |
Countries
Korea, Republic of
Contacts
Public ContactJi Sung Kim
Asan Medical Center
Outcome results
None listed