Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522867
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Evaluation of Intraocular Pressure Following a Vitreoretinal Surgery Using Goldmann Applanation Tonometry Icare and Accupen
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Reliability Evaluation of Intraocular Pressure At Day 1 Following Vitreoretinal Surgery Comparing Goldmann Applanation Tonometry Gold Standard to Icare and Accupen
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Participants in this study will have their IOP measured by the three different instruments one day post-surgery
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 andor 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 andor Accupen is as valid as that taken by Goldmans applanation tonometry
The objective of this study is therefore to determine whether the IOP measured by Accupen andor 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 andor Accupen is as valid as that taken by Goldmans applanation tonometry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None