SENSIMED Triggerfish Sensor Sizes

Phase 4CompletedNCT01972997

Sensimed AG14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

SENSIMED TriggerfishDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clinico San Carlos

Madrid, Spain

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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