INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY

November 24, 2024 updated by: Dr. Kenneth Eng, Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. All patients undergoing Pars Plana Vitrectomy between June 25, 2024 - and December 30, 2024, will be included.
  2. Patients aged 18 years or older
  3. Patients able to give informed consent

Exclusion Criteria:

  1. Patients with complicated Pars Plana Vitrectomy (choroidal hemorrhage, retrobulbar hemorrhage)
  2. Patients with irregular cornea surface will be excluded (keratoconus, band keratopathy, corneal edema, corneal transplant, cornea scarring)
  3. Patients undergoing combined scleral buckling at time of surgery
  4. Patients with previous glaucoma filtration surgery (ie. trabeculectomy or tube shunt surgery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surgeon #1
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
Digital palpation for IOP measurement
Diagnostic test: Cotton-tipped applicator (CTA)
Cotton-tipped applicator (CTA) for IOP measurement
Other: Surgeon #2
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
Digital palpation for IOP measurement
Diagnostic test: Cotton-tipped applicator (CTA)
Cotton-tipped applicator (CTA) for IOP measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure measurement
Time Frame: From enrolment to end of treatment at 8 weeks
Intraocular pressure accuracy between surgeons' estimate and tonometer IOP measurement.
From enrolment to end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure measuring agreement
Time Frame: From enrolment to end of treatment at 8 weeks
  1. Intraocular pressure surgeon measuring agreement with digital palpation.
  2. Intraocular pressure surgeon measuring agreement with short wooden stick cotton swab.
From enrolment to end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No identifying information will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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