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
1 other identifier
interventional
67
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2024
CompletedFirst Posted
Study publicly available on registry
July 26, 2024
CompletedStudy Start
First participant enrolled
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
ExpectedSeptember 26, 2024
July 1, 2024
5 months
July 16, 2024
September 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Reliability and validity of devices at all intracular pressure level
at the post-operative visit (1 day after surgery)
Study Arms (1)
Intraocular pressure measure
EXPERIMENTALInterventions
The intraocular pressure of the subjects using either the Goldmann applanation tonometer, Icare or Accupen. The order of the measure is randomized.
Eligibility Criteria
You may qualify if:
- Age ≥ 18
- Received a vitreoretinal surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
Québec, Quebec, G1S4L8, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Mathieu Caissie, MD
CHU de Québec - Université Laval
- PRINCIPAL INVESTIGATOR
Imad E Hachem, MD
CHU de Québec - Université Laval
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2024
First Posted
July 26, 2024
Study Start
August 5, 2024
Primary Completion
January 1, 2025
Study Completion (Estimated)
August 1, 2027
Last Updated
September 26, 2024
Record last verified: 2024-07