Evaluation of Intraocular Pressure Following a Vitreoretinal Surgery Using Goldmann Applanation Tonometry, Icare and Accupen

Reliability Evaluation of Intraocular Pressure At Day 1 Following Vitreoretinal Surgery, Comparing Goldmann Applanation Tonometry (Gold Standard) to Icare and Accupen

The goal of this prospective controlled study is to measure the reliability of two intraocular pressure (IOP)-measuring instruments in comparison to the gold standard, Goldmann applanation tonometry (GAT) following vitreo-retinal surgery. The main question the current study aims to answer is: are Icare and Accupen as accurate as GAT in measuring IOP one day post eye surgery?

Participants in this study will have their IOP measured by the three different instruments one day post-surgery.

Study Overview

• Status: Recruiting
• Conditions: Intraocular Pressure
• Intervention / Treatment: Other: Intraocular pressure measure

Detailed Description

Goldmann applanation tonometry (GAT), used since 1948, is the reference technique for measuring intraocular pressure (IOP) in both healthy patients and those suffering from glaucoma or other eye disorders. However, the use of GAT requires the topical application of fluorescein, local anesthesia, and direct contact with the cornea. In addition to its lack of portability, these characteristics of GAT quickly led clinicians to try to find simpler, less cumbersome, but just as reliable techniques to measure IOP. Among the techniques developed to potentially replace GAT, two portable techniques are particularly easy to use: rebound tonometry (Icare) and portable applanation tonometry (Accupen). Before these techniques are universally and interchangeably used with GAT, their reliability and accuracy must be measured. The majority of studies have evaluated these techniques in glaucomatous or healthy eyes, presenting mixed but promising results. However, only one recent study has evaluated the validity of the two techniques (Icare and TonoPen) in a post-operative context of vitreo-retinal surgery. More data is therefore necessary to come to a definitive conclusion regarding the reliability of Icare and Accupen.

The objective of this study is therefore to determine whether the IOP measured by Accupen and/or Icare is as accurate as that taken by GAT in patients who have undergone vitreo-retinal surgery.

To answer this question, this project will be a prospective controlled study of 67 patients who have undergone vitreo-retinal surgery and who will have their intraocular pressure taken 1 day post-operatively by the 3 instruments mentioned above, in a randomized order. At their 1-day post-operative visit, an ocular medical history will be taken, including the preoperative diagnosis and the type of surgery performed. A resident in ophthalmology at Laval University, will take a series of 2 intraocular pressures with these 3 devices: GAT, Icare, and Accupen and will average for each group.

The project research hypothesis would be that the taking of intraocular pressure by Icare and/or Accupen is as valid as that taken by Goldman's applanation tonometry.

• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Mauger, BSc; Phone Number: 84821 418-682-7511; Email: cuo.recherche@fmed.ulaval.ca
• Study Contact Backup: Name: Sébastien Méthot, PhD; Phone Number: 84821 418-682-7511; Email: sebastien.methot@crchudequebec.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1S4L8
      • Recruiting
      • Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
      • Contact: Mathieu Caissie, MD
      • Contact: Imad E Hachem, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18
• Received a vitreoretinal surgery

Exclusion Criteria:

• Corneal dystrophy
• Corneal surgery (penetrating keratoplasty, DSAEK/DMEK less than 6 months, radial keratotomy)
• Irregular corneal surface
• Active corneal ulcer
• Active epithelial deficit
• Central corneal scarring
• A history of scleral buckle

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraocular pressure measure	Other: Intraocular pressure measure; The intraocular pressure of the subjects using either the Goldmann applanation tonometer, Icare or Accupen. The order of the measure is randomized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of difference between intracular pressure measured by devices	No difference in the intraocular pressure measured by Accupen or Icare compared to Goldmann tonometer.	at the post-operative visit (1 day after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability and validity of devices at all intracular pressure level	The devices have the same intraocular pressure measured by Goldmann tonometer at High level of pressure (>24mmHg), moderate level (10-24mmHg) and low level (<10mmHg).	at the post-operative visit (1 day after surgery)

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Mathieu Caissie, MD, CHU de Quebec - Universite Laval; Principal Investigator: Imad E Hachem, MD, CHU de Quebec - Universite Laval

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Intraocular Pressure; vitrectomy; Goldmann; Accupen; Icare
• Other Study ID Numbers: 2024-7144

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No