SENSIMED Triggerfish Sensor Sizes

Sensimed

Status and phase: Completed; Phase 4

Conditions: Healthy Volunteers

Treatments: Device: SENSIMED Triggerfish

Study type: Interventional

Funder types: Industry

Identifiers

NCT01972997

TF-1220

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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14 participants in 1 patient group

SENSIMED Triggerfish

Experimental group

Description:

There is only 1 arm in the study. SENSIMED Trigerfish lens sensors with different base curves are placed on subjects in random and double-blinded manner in sequential sessions.

Treatment:

Device: SENSIMED Triggerfish