Intraocular PressureNCT06522867
Evaluation of Intraocular Pressure Following a Vitreoretinal Surgery Using Goldmann Applanation Tonometry, Icare and Accupen
A study testing Intraocular pressure measure in people with Intraocular Pressure, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Intraocular pressure measure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- 5 Aug 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Received a vitreoretinal surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hôpital du Saint-Sacrement, CHU de Québec - Université Laval
Québec, Quebec, G1S4L8
Mathieu Caissie, MD
Imad E Hachem, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraocular Pressure
- Being tested
- Intraocular pressure measure
- Keywords
- Intraocular Pressure, Accupen, Icare, Goldmann, vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure measureOther
The intraocular pressure of the subjects using either the Goldmann applanation tonometer, Icare or Accupen. The order of the measure is randomized.
| Study group | Role | What they receive |
|---|---|---|
| Intraocular pressure measure | Experimental | Not described Receives: Other: Intraocular pressure measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of difference between intracular pressure measured by devices
No difference in the intraocular pressure measured by Accupen or Icare compared to Goldmann tonometer.
Measured: at the post-operative visit (1 day after surgery)
Secondary outcomes (1)
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).
Measured: at the post-operative visit (1 day after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start5 Aug 2024
- Primary completionJan 2025 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu Caissie, MD, Principal investigator, CHU de Québec - Université LavalImad E Hachem, MD, Principal investigator, CHU de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522867
- Sponsor's protocol ID
- 2024-7144
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability Evaluation of Intraocular Pressure At Day 1 Following Vitreoretinal Surgery, Comparing Goldmann Applanation Tonometry (Gold Standard) to Icare and Accupen
- ClinicalTrials.gov ID
- NCT06522867
- Acronym / sponsor ID
- 2024-7144
- Conditions
- Intraocular Pressure
- Keywords
- Intraocular Pressure, Accupen, Icare, Goldmann, vitrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraocular pressure measure | Experimental | Other: Intraocular pressure measure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- Received a vitreoretinal surgery
Key exclusion criteria (7 listed)
- Corneal dystrophy
- Corneal surgery (penetrating keratoplasty, DSAEK/DMEK less than 6 months, radial keratotomy)
- Irregular corneal surface
- Active corneal ulcer
- Active epithelial deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular pressure measureThe intraocular pressure of the subjects using either the Goldmann applanation tonometer, Icare or Accupen. The order of the measure is randomized. | Other | Intraocular pressure measure |
Primary outcome
Absence of difference between intracular pressure measured by devices
Time frame: at the post-operative visit (1 day after surgery)
No difference in the intraocular pressure measured by Accupen or Icare compared to Goldmann tonometer.
1 secondary outcome
Reliability and validity of devices at all intracular pressure level
Time frame: at the post-operative visit (1 day after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathieu Caissie, MD principal investigator
CHU de Québec - Université Laval
Imad E Hachem, MD principal investigator
CHU de Québec - Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular pressure measure in people with Intraocular Pressure, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Mauger, BSc (418-682-7511 ext. 84821, cuo.recherche@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of difference between intracular pressure measured by devices (time frame: at the post-operative visit (1 day after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.