- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07022054
iCare IC1000 Alignment Study: Evaluating Ease of Use for Eye Pressure Measurement
The iCare IC1000 Alignment Study is an important clinical trial designed to evaluate how effectively the alignment feature of the iCare IC1000 tonometer helps healthcare providers measure intraocular pressure (IOP) in adult patients. This non-invasive device is used to check the pressure inside the eye, which is crucial for diagnosing and monitoring conditions like glaucoma.
This study will involve approximately 100 participants, including healthy volunteers aged 18 and older. Researchers want to determine how often the alignment feature successfully helps obtain accurate IOP measurements during a single clinic visit. The trial is particularly significant because proper IOP measurement is essential for detecting eye health issues early, when they're most treatable.
Key aspects of the study include:
- Single clinic visit lasting about 2 months on average
- Open-label design (both patients and doctors know they're using the IC1000)
- Focus on the device's alignment feature usability
- Participation available for healthy adults and older adults
The study has specific eligibility requirements to ensure participant safety and accurate results. People cannot participate if they have certain eye conditions like corneal scarring, keratoconus, or severe dry eyes, or if they've worn hard contact lenses within 24 hours before measurement. These restrictions help researchers get the clearest picture of how well the device works under typical clinical conditions.
Intraocular pressure measurement is a critical component of comprehensive eye care. Elevated IOP is the primary risk factor for glaucoma, a leading cause of irreversible blindness worldwide. Traditional methods of measuring eye pressure can sometimes be uncomfortable or challenging to perform accurately. The iCare IC1000 represents an innovative approach that may make this important diagnostic test easier and more comfortable for patients while providing reliable results for eye care professionals.
This research is particularly valuable because it focuses on the practical usability of the device in real clinical settings. While many studies examine accuracy, understanding how consistently healthcare providers can achieve proper alignment - a key factor in obtaining accurate readings - is equally important for day-to-day patient care.
The study is sponsored by Icare Finland Oy and will be conducted under the guidance of Dr. Monique Barbour. The relatively short duration (from May to July 2025) means results should be available relatively soon, potentially contributing to improved eye care practices if the alignment feature proves effective.
For patients concerned about eye health, particularly those at risk for glaucoma, studies like this represent important progress in diagnostic technology. Easier, more comfortable pressure measurements could lead to earlier detection of problems and better monitoring of existing conditions. The inclusion of healthy volunteers also helps establish baseline data about the device's performance across a broad population.
As with any medical device study, the ultimate goal is to improve patient care. The iCare IC1000 alignment study represents an exciting opportunity to potentially make routine eye pressure checks more efficient and accessible, benefiting both patients and eye care providers. While this specific study focuses on the technical aspect of alignment, its outcomes could have meaningful implications for how easily and accurately eye pressure can be monitored in clinical practice moving forward.
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