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Not yet recruiting NCT06707168

INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY

No phase Interventional Pars Plana Vitrectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital palpation, Cotton-tipped applicator (CTA).
Who it may be relevant to
Registry conditions: Pars Plana Vitrectomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ACCURACY of DIGITAL INTRAOCULAR PRESSURE MEASUREMENT AT the END of PARS PLANA VITRECTOMY SURGERY

Overview

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.

Interventions

  • Diagnostic test Digital palpation
    Digital palpation for IOP measurement
  • Diagnostic test Cotton-tipped applicator (CTA)
    Cotton-tipped applicator (CTA) for IOP measurement

Primary outcome measures

  • Intraocular pressure measurement [Time frame: From enrolment to end of treatment at 8 weeks]
Secondary outcome measures (1)
  • Intraocular pressure measuring agreement [Time frame: From enrolment to end of treatment at 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 18398355
  • 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
  • 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

Identifiers

NCT: NCT06707168 · 6310

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗