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OpenTrials
Completed

NCT Number: NCT01972997

SENSIMED Triggerfish Sensor Sizes

This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4 24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor lens sizes is placed on the eye in the different sessions. Subjects visit the study site for installation and removal of the device and accompanying exams, but remain ambulatory during the recording.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinico San Carlos

Madrid, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subject without previous ocular disease
  • Aged ≥ 18 years, of either sex
  • Central corneal radius (flat meridian) between 7.75 mm and 8.25 mm in at least one eye
  • 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
  • Severe dry eye 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
  • Any other contra-indication listed in the TF user manual

Treatment and study plan

SENSIMED Triggerfish

Device

Primary outcomes

  1. The effect of the sensor lens size on IOP patterns as recorded by TF (SENSIMED Triggerfish) as compared to the recommended sensor lens fit

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Sensimed AG

Industry

Registry information

Official study title

A Single-center, Randomized, Double-blinded, Prospective Study to Assess the Changes in the 24-hour IOP (Intraocular Pressure) Pattern in Relation to SENSIMED Triggerfish® Sensor Sizes in Healthy Subjects

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2013
Registry last updated
Nov 17, 2015

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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