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OpenTrials
Completed

NCT Number: NCT01906502

24-hour IOP Pattern With SENSIMED Triggerfish® in a Healthy Population

A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now on healthy volunteers and patients with glaucoma. However, healthy subjects were much younger than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish database was almost twice higher than the number of healthy subjects. As it is generally accepted that intra ocular pressure (IOP) in the aging population is higher than IOP in young adults it is of interest to evaluate the 24-hour IOP pattern of older healthy subjects. Furthermore, improving our knowledge of the "healthy" 24-hour IOP pattern in comparison to glaucoma profiles would be beneficial for management of glaucoma.

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Key information

Conditions

Healthy Subject

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meir Medical Center, Kfar Saba, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject of Caucasian origin
  • Healthy subject without previous ocular disease
  • Aged between 40 and 80 years, of either sex
  • Not more than 6 diopters spherical equivalent in the study eye
  • Having given written informed consent, prior to any investigational procedures

Exclusion criteria

  • Corneal or conjunctival abnormality precluding contact lens adaptation
  • Previous refractive surgery
  • Occludable or closed iridocorneal angle
  • Sleep apnea syndrome
  • Subjects with allergy to corneal anesthetic
  • Subjects with contraindications for silicone contact lens wear
  • Subjects not able to understand the character and individual consequences of the investigation
  • Participation in other clinical research within the last 4 weeks

Treatment and study plan

SENSIMED Triggerfish

Device

Primary outcomes

  1. The 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary

    Time frame: 24-hour

Secondary outcomes

  1. Diurnal and nocturnal IOP patterns in healthy subjects

    Time frame: 24 hours

  2. Assessment of corneal biomechanical properties in healthy population (if available)

    Time frame: 24 hours

  3. Relationship between the 24-hour IOP pattern monitored by TF and the 24-hour blood pressure pattern in healthy subjects (if available)

    Time frame: 24 hours

  4. Assessment of Safety and tolerability through adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Registry information

Official study title

A Prospective, Open Label Study to Assess the 24-hour IOP Pattern Recorded With SENSIMED Triggerfish® in a Healthy Population

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2013
Registry last updated
Aug 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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