IOP Device Comparison Study

NCT04211792 | Completed

• 1 other identifier: Tonometry
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraocular Pressure

Keywords

Tonometry, Ocular; Concordance; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Concordance in IOP 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.

• Concordance among tonometers in low IOP range

  It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.

• Concordance among tonometers in medium IOP range

  It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.

• Concordance among tonometers in high IOP range

  It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.

• Proportion of Icare IOP measurements with GAT recordings

  It's a single visit study and it is anticipated that study procedures will increase the duration of the clinic visit by 20 minutes.

Study Arms (1)

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.

Device: Icare Tonometer

Interventions

Icare Tonometer DEVICE

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.

Glaucoma suspect or patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glaucoma suspects or patients who are older than 18 years are invited to participate in this study.

You may qualify if:

• Age greater than 18 years
• Willingness to participate in all study procedures, along with signed written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Ivey Eye Institute at St Joseph hospital

London, Ontario, N6A 4V2, Canada

Location

Related Publications (13)

• 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.

  PMID: 30034218 RESULT

• 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.

  PMID: 8628552 RESULT

• 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.

  PMID: 18303384 RESULT

• 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.

  PMID: 23521889 RESULT

• 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.

  PMID: 30047543 RESULT

• 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.

  PMID: 19788665 RESULT

• 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.

  PMID: 26408266 RESULT

• 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.

  PMID: 31210982 RESULT

• 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.

  PMID: 30689609 RESULT

• 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.

  PMID: 18196259 RESULT

• 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.

  PMID: 16778643 RESULT

• 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.

  PMID: 31466475 RESULT

• 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.

  PMID: 24006952 RESULT

Study Officials

• Tony Lin, MD

  Ivey Eye Institute- St Joseph's hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2019
• First Posted: December 26, 2019
• Study Start: March 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: September 2, 2021

Record last verified: 2020-06

Locations

CA (1)