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Reliability of Dynamic Contour Tonometry (DCT)

U

University of Catanzaro

Status and phase

Completed
Phase 4

Conditions

Intraocular Pressure
Central Corneal Thickness

Treatments

Device: DCT (PASCAL© Tonometer) IOP and OPA measurement

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the gold standard technique.

Full description

Healthy volunteers recruited among subjects who underwent a routine ophthalmologic evaluation or among students and workers both at our clinic, will undergo a series of 5 DCT to evaluate eventual differences among the measurements.

A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be taken 1 to 7 days before the DCT.

At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes versus previous GAT values obtained through the diurnal curve.

After 3 weeks observers will contact patients to record eventual adverse events. If examiners consider it as necessary, a safety ophthalmological evaluation will then be performed.

Enrollment

102 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy subjects giving a valid consent to be included in this experimentation
  • age between 18 and 80 years
  • best corrected visual acuity (BCVA) of at least 20/100
  • refraction ranging from -6 to +6 dioptres, with an astigmatism ranging from -2 to +2 dioptres

Exclusion criteria

  • History of refractive surgery or any keratoplasty procedure.
  • Corneal opacities or diseases making no suitable applanation tonometry.
  • Use of contact lenses. History of glaucoma or ocular hypertension.
  • History of diabetic retinopathy staged as severe non-proliferative or worse.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

102 participants in 1 patient group

Dynamic Contour Tonometry
Experimental group
Description:
All recruited volunteers in present study, that underwent diurnal GAT tonometry (3 measures) and 5 DCT measurements.
Treatment:
Device: DCT (PASCAL© Tonometer) IOP and OPA measurement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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