IOP Device Comparison Study

Intraocular Pressure Clinical Trial

Official title:

Comparison of Intraocular Pressure Measurements Between Icare PRO, Icare ic200, and Goldmann Applanation Tonometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211792
• Other study ID #: Tonometry
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: June 2020
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Intraocular pressure measurement (IOP) is part of a routine eye examination. High and low eye pressure may be linked to certain eye conditions such as glaucoma. The current gold standard for IOP measurement is a technique called Goldmann Applanation Tonometry (GAT). GAT requires the use of a Goldmann applanation tonometer mounted on a slit lamp. Apart from GAT, there are many other devices that can be used to measure IOP, including the iCare tonometers. In this prospective study, investigators will be measuring participant's IOP with GAT, Icare PRO, and Icare ic200 tonometers to see if there is an agreement in IOP between the different devices. Investigator will also look if there is a concordance between different tonometers in low, moderate and high IOP range. Given the postural requirements for performing GAT, patients with higher body mass index (BMI) tend to have difficulties with proper positioning at the slit lamp that may lead to inaccurate GAT measurements. To this end, investigators will analyze the effect of BMI on IOP measurements with different devices. Additionally, comfort level of the patients with different tonometry devices will be recorded using a visual analog scale.

Description:

Intraocular pressure measurement (IOP) is a vital part of the routine eye examination. High and low eye pressure may be associated with various ocular pathologies, including glaucoma. The current gold standard for IOP measurement is Goldmann Applanation Tonometry (GAT). To perform measurements with GAT, topical anaesthetic and fluorescein eye drops are applied to the eye. The Goldmann tonometer tip directly contacts the cornea and measures the intraocular pressure by the Imbert-Fick principle. IOP measurement is generally performed by a trained and experienced ophthalmologist or ophthalmic technician on patients in an upright position. There may be minor discomfort associated with the use of topical anaesthetic in this technique.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 18 years

• Willingness to participate in all study procedures, along with signed written consent

Exclusion Criteria:

• Age younger than 18 years

• 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

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Ivey Eye Institute at St Joseph hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (13)

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. E — View Citation

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 — View Citation

Nakakura S. Icare(®) 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. Review. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Rödter TH, Knippschild S, Baulig C, Krummenauer F. Meta-analysis of the concordance of Icare(®) 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 A — View Citation

Schweier C, Hanson JV, Funk J, Töteberg-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 — View Citation

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 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance in IOP between GAT and Icare ic200	Primary objective of this study is to compare overall Mean IOP between GAT and Icare ic200	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Secondary	Concordance in IOP between GAT and Icare PRO	To compare the overall IOP measurements between GAT and Icare PRO.	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Secondary	Concordance among tonometers in low IOP range	To compare IOP measurements between GAT and Icare PRO/Icare ic200 in low IOP range (7-15 mmHg).	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Secondary	Concordance among tonometers in medium IOP range	To compare IOP measurements between GAT and Icare PRO/Icare ic200 in medium IOP range (16-22 mmHg).	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Secondary	Concordance among tonometers in high IOP range	To compare IOP measurements between GAT and Icare PRO/Icare ic200 in high IOP range (23-60 mmHg).	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Secondary	Proportion of Icare IOP measurements with GAT recordings	To determine the proportion of IOP measurements from Icare PRO and Icare ic200 that are within ±2 mmHg, ±3 mmHg and ±5 mmHg of the GAT measurements.	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Secondary	Corelation between GAT and Icare Tonometers	To find the correlation in the IOP measurement between GAT and Icare PRO and also between GAT and Icare ic200.	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Secondary	Corelation between central corneal thickness (CCT) and IOP	To evaluate the effect of central corneal thickness (CCT) on IOP measurement by GAT, Icare PRO and Icare ic200.	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Secondary	Effect of BMI on IOP	To evaluate the effects of BMI on IOP measurement by GAT, Icare PRO, Icare ic200.	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.
Secondary	Patient comfort during tonometry	To evaluate patient comfort during tonometry measurements with each device using a Visual Analog Scale (VAS).	It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.