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Accuracy of Handheld and Non-contact Tonometry

B

Benha University

Status

Unknown

Conditions

Glaucoma
Intraocular Pressure
Glaucoma, Suspect

Treatments

Diagnostic Test: Intraocular pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT05352906
RC-10-2022

Details and patient eligibility

About

Monitoring the intraocular pressure (IOP) is one of the most important tests used in follow-up among glaucoma suspects and confirmed glaucomatous patients.

Full description

In tertiary hospitals, IOP screening is an important tool to confirm glaucomatous eyes. Inaccurate measurements may lead to missed diagnosis or false positive results that may affect patients' quality of life.

There are many devices produced to measure IOP, the commonest one is Goldman contact tonometry, the aim of this study is to compare the results of new developed tonometers to the standard applanation tonometer.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All subjects seeking regular check-up in glaucoma clinic at banha university hospital.
  • Glaucoma suspects and glaucomatous patients that visit glaucoma clinic for regular IOP measurements.

Exclusion criteria

  • Patients that will refuse to measure IOP again with other devices.
  • patients with previous corneal surgeries or scar that may alter the measurements of the tonometer s (as previous keratoplasty, trauma or opacities).

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 3 patient groups

Contact goldman applanation tonometry
Active Comparator group
Description:
The standard contact tonometer
Treatment:
Diagnostic Test: Intraocular pressure
Handheld digital contact tonometer
Active Comparator group
Description:
A contact digital tonometer's pen.
Treatment:
Diagnostic Test: Intraocular pressure
Non-contact air-puff tonometer
Active Comparator group
Description:
A non-contact tonometer based on air-puff and corneal hysteresis.
Treatment:
Diagnostic Test: Intraocular pressure

Trial contacts and locations

1

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Central trial contact

Ahmed Abdelshafy, MD

Data sourced from clinicaltrials.gov

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