INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY

NCT06707168 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 6310
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 pressure against a standardized instrument designed for this purpose.

Conditions

Pars Plana Vitrectomy

Keywords

intraocular pressure; pars plana vitrectomy

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure measurement

  Intraocular pressure accuracy between surgeons' estimate and tonometer IOP measurement.

  From enrolment to end of treatment at 8 weeks

Secondary Outcomes (1)

• Intraocular pressure measuring agreement

  From enrolment to end of treatment at 8 weeks

Study Arms (2)

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.

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.

Diagnostic Test: Digital palpation; Diagnostic Test: Cotton-tipped applicator (CTA)

Interventions

Digital palpation DIAGNOSTIC_TEST

Digital palpation for IOP measurement

Surgeon #1; Surgeon #2

Cotton-tipped applicator (CTA) DIAGNOSTIC_TEST

Cotton-tipped applicator (CTA) for IOP measurement

Surgeon #1; Surgeon #2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Related Publications (3)

• 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.

  PMID: 18398355 BACKGROUND

• Wilde 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.

  PMID: 32488595 BACKGROUND

• Alexander 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.

  PMID: 26315702 BACKGROUND

MeSH Terms

Interventions

Digital Rectal Examination

Intervention Hierarchy (Ancestors)

Palpation; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Kenneth Eng, MD

CONTACT

416-480-4688; Kenneth.Eng@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Ophthalmology

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share