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SENSIMED Triggerfish Discomfort During IOP Monitoring

Evaluation of SENSIMED Triggerfish for 24 Hour IOP Monitoring in Healthy Subjects and Glaucoma Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00966108
Acronym
09/02
Enrollment
40
Registered
2009-08-26
Start date
2009-08-31
Completion date
2010-01-31
Last updated
2010-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients

Brief summary

Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens

Interventions

Ocular Telemetry Sensor for IOP monitoring

Sponsors

Sensimed AG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Patient is able to comply with the study procedure * Patient is 18-80 years old * Healthy subject or glaucoma patient * Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out * Cylinder refraction of no more than +/- 2 diopters in the study eye * Visual acuity of 20/80 or better in the study eye * Ability of subject to understand the character and individual consequences of the study * For women with childbearing potential, adequate contraception

Exclusion criteria

* Subjects wearing contact lenses within the last two years * Subjects with contraindications for wearing contact lenses * History of refractive surgery * History of intraocular surgery in the last three months * Severe dry eye syndrome * Keratoconus or other corneal abnormalities * Conjunctival or intraocular inflammation * Pregnancy and lactation * Simultaneous participation in other clinical trials

Design outcomes

Primary

MeasureTime frame
ocular discomfort on a visual analogue scale24 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026