Pars Plana VitrectomyNCT06707168
INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY
A study testing Digital palpation and Cotton-tipped applicator (CTA) in people with Pars Plana Vitrectomy, run by Sunnybrook Health Sciences Centre.
Trial summary
Intraocular pressure is measured regularly at any and all visits with your eye doctor or optometrist. The purpose of this study is to compare measurements of eye pressure at the end of the surgery, comparing the ability of a gloved finger or sterile cotton-tipped applicator ("Q-tip") to accurately measure intraocular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pars Plana Vitrectomy
- What is being tested?
- Digital palpation and Cotton-tipped applicator (CTA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to Dec 2025
- 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
- All patients undergoing Pars Plana Vitrectomy between June 25, 2024 - and December 30, 2024, will be included.
- Patients aged 18 years or older
- Patients able to give informed consent
Who cannot join
- Patients with complicated Pars Plana Vitrectomy (choroidal hemorrhage, retrobulbar hemorrhage)
- Patients with irregular cornea surface will be excluded (keratoconus, band keratopathy, corneal edema, corneal transplant, cornea scarring)
- Patients undergoing combined scleral buckling at time of surgery
- Patients with previous glaucoma filtration surgery (ie. trabeculectomy or tube shunt surgery)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ACCURACY of DIGITAL INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY SURGERY
Intraocular pressure is measured regularly at any and all visits with your eye doctor or optometrist.
The purpose of this study is to compare measurements of eye pressure at the end of the surgery, comparing the ability of a gloved finger or sterile cotton-tipped applicator ("Q-tip") to accurately measure intraocular pressure against a standardized instrument designed for this purpose.
- Conditions
- Pars Plana Vitrectomy
- Being tested
- Digital palpation, Cotton-tipped applicator (CTA)
- Keywords
- intraocular pressure, pars plana vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital palpationDiagnostic test
Digital palpation for IOP measurement
Cotton-tipped applicator (CTA)Diagnostic test
Cotton-tipped applicator (CTA) for IOP measurement
| Study group | Role | What they receive |
|---|---|---|
| Surgeon #1 | Other | One by digital palpation over the limbal area; and the other using a short wooden cotton-tipped applicator (CTA) over the limbal area. Receives: Diagnostic Test: Digital palpation; Diagnostic Test: Cotton-tipped applicator (CTA) |
| Surgeon #2 | Other | One by digital palpation over the limbal area; and the other using a short wooden cotton-tipped applicator (CTA) over the limbal area. Receives: Diagnostic Test: Digital palpation; Diagnostic Test: Cotton-tipped applicator (CTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure measurement
Intraocular pressure accuracy between surgeons' estimate and tonometer IOP measurement.
Measured: From enrolment to end of treatment at 8 weeks
Secondary outcomes (1)
Intraocular pressure measuring agreement
- Intraocular pressure surgeon measuring agreement with digital palpation.
- Intraocular pressure surgeon measuring agreement with short wooden stick cotton swab.
Measured: From enrolment to end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Mar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pars Plana VitrectomyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kenneth Eng, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707168
- Sponsor's protocol ID
- 6310
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No identifying information will be shared
Publications
Acar N, Kapran Z, Unver YB, Altan T, Ozdogan S. Early postoperative hypotony after 25-gauge sutureless vitrectomy with straight incisions. Retina. 2008 Apr;28(4):545-52. doi: 10.1097/IAE.0b013e318162b008.
PubMed 18398355Wilde C, Bhardwaj P, King A, Kumudhan D, Foss A, Orr G, Zaman A. First postoperative day review in eyes undergoing pars plana vitrectomy, encirclement and endotamponade to check intraocular pressure: Is it necessary? Int Ophthalmol. 2020 Oct;40(10):2577-2583. doi: 10.1007/s10792-020-01438-w. Epub 2020 Jun 1.
PubMed 32488595Alexander P, Michaels L, Newsom R. Is day-1 postoperative review necessary after pars plana vitrectomy? Eye (Lond). 2015 Nov;29(11):1489-94. doi: 10.1038/eye.2015.134. Epub 2015 Aug 28.
PubMed 26315702
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCURACY of DIGITAL INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY SURGERY
- ClinicalTrials.gov ID
- NCT06707168
- Acronym / sponsor ID
- 6310
- Conditions
- Pars Plana Vitrectomy
- Keywords
- intraocular pressure, pars plana vitrectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Nov 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.
Intraocular pressure is measured regularly at any and all visits with your eye doctor or optometrist.
The purpose of this study is to compare measurements of eye pressure at the end of the surgery, comparing the ability of a gloved finger or sterile cotton-tipped applicator ("Q-tip") to accurately measure intraocular pressure against a standardized instrument designed for this purpose.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon #1 | Other | Diagnostic Test: Digital palpation, Diagnostic Test: Cotton-tipped applicator (CTA)One by digital palpation over the limbal area; and the other using a short wooden cotton-tipped applicator (CTA) over the limbal area. |
| Surgeon #2 | Other | Diagnostic Test: Digital palpation, Diagnostic Test: Cotton-tipped applicator (CTA)One by digital palpation over the limbal area; and the other using a short wooden cotton-tipped applicator (CTA) over the limbal area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing Pars Plana Vitrectomy between June 25, 2024 - and December 30, 2024, will be included.
- Patients aged 18 years or older
- Patients able to give informed consent
Key exclusion criteria (4 listed)
- Patients with complicated Pars Plana Vitrectomy (choroidal hemorrhage, retrobulbar hemorrhage)
- Patients with irregular cornea surface will be excluded (keratoconus, band keratopathy, corneal edema, corneal transplant, cornea scarring)
- Patients undergoing combined scleral buckling at time of surgery
- Patients with previous glaucoma filtration surgery (ie. trabeculectomy or tube shunt surgery)
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 |
|---|---|---|
| Digital palpationDigital palpation for IOP measurement | Diagnostic test | Surgeon #1, Surgeon #2 |
| Cotton-tipped applicator (CTA)Cotton-tipped applicator (CTA) for IOP measurement | Diagnostic test | Surgeon #1, Surgeon #2 |
Primary outcome
Intraocular pressure measurement
Time frame: From enrolment to end of treatment at 8 weeks
Intraocular pressure accuracy between surgeons' estimate and tonometer IOP measurement.
1 secondary outcome
Intraocular pressure measuring agreement
Time frame: From enrolment to end of treatment at 8 weeks
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 27 Nov 2024.
- Background: PubMed 18398355Acar N, Kapran Z, Unver YB, Altan T, Ozdogan S. Early postoperative hypotony after 25-gauge sutureless vitrectomy with straight incisions. Retina. 2008 Apr;28(4):545-52. doi: 10.1097/IAE.0b013e318162b008.
- Background: PubMed 32488595Wilde C, Bhardwaj P, King A, Kumudhan D, Foss A, Orr G, Zaman A. First postoperative day review in eyes undergoing pars plana vitrectomy, encirclement and endotamponade to check intraocular pressure: Is it necessary? Int Ophthalmol. 2020 Oct;40(10):2577-2583. doi: 10.1007/s10792-020-01438-w. Epub 2020 Jun 1.
- Background: PubMed 26315702Alexander P, Michaels L, Newsom R. Is day-1 postoperative review necessary after pars plana vitrectomy? Eye (Lond). 2015 Nov;29(11):1489-94. doi: 10.1038/eye.2015.134. Epub 2015 Aug 28.
- Individual participant dataSharing planned: No. No identifying information will be shared
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Digital palpation and Cotton-tipped applicator (CTA) in people with Pars Plana Vitrectomy, run by Sunnybrook Health Sciences Centre.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Kenneth Eng, MD (416-480-4688, Kenneth.Eng@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure measurement (time frame: From enrolment to end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06707168, which also lists 3 linked publications.
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 27 Nov 2024.