A prospective, single-center, open-Label, investigator initiated trial to compare the efficacy and safety of non-contact tonometer(HNT-1/P) and goldmann applanation tonometer for intraocular pressure measurements
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0002549
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
[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
[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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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