Study Results
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Basic Information
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COMPLETED
101 participants
OBSERVATIONAL
2020-03-01
2021-07-31
Brief Summary
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Detailed Description
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Icare tonometers are a new class of rebound tonometers used for IOP measurements. A disposable tip of the Icare tonometer is propelled towards the cornea and the deceleration of the tip is measured to calculate the IOP. The Icare series of devices are hand-held tonometers, which are easy to operate and do not require topical anaesthesia for IOP measurements.
Despite being the most reliable and clinically validated method to measure IOP, GAT has several limitations. First, it requires extensive training and experience to accurately measure IOP. Moreover, IOP measurement with GAT may be associated with minor discomfort due to the need for topical anaesthesia. Apart from that, GAT is not a portable device and the patient needs to be seated upright, making it difficult to perform in certain populations, such as pediatric, elderly and those with high BMI. Several hand-held tonometers are available, including the Icare series. These tonometers allow for quick, portable, and arguably easier IOP measurements. These tonometers do not require as rigorous training to use. However, there is an inconsistency in the data to verify if the IOP measurements by Icare is in concordance with GAT measurements. Recent Meta-analysis by Rödter and colleagues neither confirm nor deny the agreement between Icare and GAT tonometers.
The purpose of the current study is to prospectively evaluate and determine the relationship of the IOP measurements obtained by Icare PRO, Icare ic200, and GAT. The study will evaluate IOP measurements in different IOP ranges (low: 7-15mmHg, Moderate: 16- 22mmHg, High: 23-60 mmHg) as well as the effects of central corneal thickness and BMI on IOP measurements. Patient comfort during tonometry will be measured using a visual analogue scale. To date, this will be the first study in Canada to compare IOP measurements between Icare PRO, Icare ic200, and GAT in different IOP ranges. Additionally, as the Icare ic200 is a new device, this will be the first study to perform a comparative functional analysis of the Icare ic200 versus GAT.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Glaucoma suspect or patients
Patients who has or suspected Glaucoma will be approached for the recruitment into this study. IOP will be measured in the sitting position with Icare tonometers in a random order in both the eyes. IOP measurements by GAT will be taken after Icare measurements followed by CCT recording with ultrasound pachymeter.
Icare Tonometer
Icare tonometers are a new class of rebound tonometers for IOP measurements. The Icare series of tonometers are hand-held tonometers, which are easy to operate and generally do not require topical anaesthesia for IOP measurements.
Interventions
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Icare Tonometer
Icare tonometers are a new class of rebound tonometers for IOP measurements. The Icare series of tonometers are hand-held tonometers, which are easy to operate and generally do not require topical anaesthesia for IOP measurements.
Eligibility Criteria
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Inclusion Criteria
* Willingness to participate in all study procedures, along with signed written consent
Exclusion Criteria
* Participants with corneal defects (edema, scarring, cicatrix, opacity)
* Participants with epithelial lesions, prior refractive surgery and keratoplasty surgery
* Participants having corneal astigmatism ≥ 3D
* Participants who wear contact lenses
* Participants with proliferative diabetic retinopathy, Uveitis
* Participants who are unable to have IOP measured by Goldmann Tonometry
* Inability to provide informed consent
* Participants with proliferative diabetic retinopathy, Uveitis
* Participation in a clinical trial with investigational products
18 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Tony Lin, MD
Role: PRINCIPAL_INVESTIGATOR
Ivey Eye Institute- St Joseph's hospital
Locations
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Ivey Eye Institute at St Joseph hospital
London, Ontario, Canada
Countries
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References
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Nakakura S. Icare(R) rebound tonometers: review of their characteristics and ease of use. Clin Ophthalmol. 2018 Jul 12;12:1245-1253. doi: 10.2147/OPTH.S163092. eCollection 2018.
Kass MA. Standardizing the measurement of intraocular pressure for clinical research. Guidelines from the Eye Care Technology Forum. Ophthalmology. 1996 Jan;103(1):183-5. doi: 10.1016/s0161-6420(96)30741-0. No abstract available.
Pakrou N, Gray T, Mills R, Landers J, Craig J. Clinical comparison of the Icare tonometer and Goldmann applanation tonometry. J Glaucoma. 2008 Jan-Feb;17(1):43-7. doi: 10.1097/IJG.0b013e318133fb32.
Kim KN, Jeoung JW, Park KH, Yang MK, Kim DM. Comparison of the new rebound tonometer with Goldmann applanation tonometer in a clinical setting. Acta Ophthalmol. 2013 Aug;91(5):e392-6. doi: 10.1111/aos.12109. Epub 2013 Mar 25.
Yildiz A, Yasar T. Comparison of Goldmann applanation, non-contact, dynamic contour and tonopen tonometry measurements in healthy and glaucomatous eyes, and effect of central corneal thickness on the measurement results. Med Glas (Zenica). 2018 Aug 1;15(2):152-157. doi: 10.17392/960-18.
Poostchi A, Mitchell R, Nicholas S, Purdie G, Wells A. The iCare rebound tonometer: comparisons with Goldmann tonometry, and influence of central corneal thickness. Clin Exp Ophthalmol. 2009 Sep;37(7):687-91. doi: 10.1111/j.1442-9071.2009.02109.x.
Grewal DS, Stinnett SS, Folgar FA, Schneider EW, Vajzovic L, Asrani S, Freedman SF, Mruthyunjaya P, Hahn P. A Comparative Study of Rebound Tonometry With Tonopen and Goldmann Applanation Tonometry Following Vitreoretinal Surgery. Am J Ophthalmol. 2016 Jan;161:22-8.e1-8. doi: 10.1016/j.ajo.2015.09.022. Epub 2015 Sep 25.
Rateb M, Abdel-Radi M, Eldaly Z, Elmohamady MN, Noor El Din A. Comparison of IOP Measurement by Goldmann Applanation Tonometer, ICare Rebound Tonometer, and Tono-Pen in Keratoconus Patients after MyoRing Implantation. J Ophthalmol. 2019 May 9;2019:1964107. doi: 10.1155/2019/1964107. eCollection 2019.
Nakakura S, Mori E, Fujio Y, Fujisawa Y, Matsuya K, Kobayashi Y, Tabuchi H, Asaoka R, Kiuchi Y. Comparison of the Intraocular Pressure Measured Using the New Rebound Tonometer Icare ic100 and Icare TA01i or Goldmann Applanation Tonometer. J Glaucoma. 2019 Feb;28(2):172-177. doi: 10.1097/IJG.0000000000001138.
Munkwitz S, Elkarmouty A, Hoffmann EM, Pfeiffer N, Thieme H. Comparison of the iCare rebound tonometer and the Goldmann applanation tonometer over a wide IOP range. Graefes Arch Clin Exp Ophthalmol. 2008 Jun;246(6):875-9. doi: 10.1007/s00417-007-0758-3. Epub 2008 Jan 12.
Brusini P, Salvetat ML, Zeppieri M, Tosoni C, Parisi L. Comparison of ICare tonometer with Goldmann applanation tonometer in glaucoma patients. J Glaucoma. 2006 Jun;15(3):213-7. doi: 10.1097/01.ijg.0000212208.87523.66.
Rodter TH, Knippschild S, Baulig C, Krummenauer F. Meta-analysis of the concordance of Icare(R) PRO-based rebound and Goldmann applanation tonometry in glaucoma patients. Eur J Ophthalmol. 2020 Mar;30(2):245-252. doi: 10.1177/1120672119866067. Epub 2019 Aug 29.
Schweier C, Hanson JV, Funk J, Toteberg-Harms M. Repeatability of intraocular pressure measurements with Icare PRO rebound, Tono-Pen AVIA, and Goldmann tonometers in sitting and reclining positions. BMC Ophthalmol. 2013 Sep 5;13:44. doi: 10.1186/1471-2415-13-44.
Other Identifiers
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Tonometry
Identifier Type: -
Identifier Source: org_study_id
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