Use of an Ocular Telemetry Sensor in Diamox Treated Patients

Sensimed

Status: Completed

Conditions: Glaucoma; Ocular Hypertension

Treatments: Device: SENSIMED Triggerfish

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01028664

09/05

Details and patient eligibility

About

A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of glaucoma or ocular hypertension
• IOP of ≥ 15 mmHg.
• Patients of either gender.
• Older than 18 years.
• Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion criteria

• Patients not able to understand the nature of the research
• Patients under tutorship
• Corneal abnormalities in both eyes
• Subjects with contraindications for wearing contact lenses
• History of ocular surgery within the last 3 months
• Known hypersensitivity to Diamox® or to any of its excipients
• Pregnancy and lactation
• Simultaneous participation in other clinical research
• Patients with evidence of ocular infection or inflammation
• History of renal or hepatic impairment, hypokalemia and hyponatremia

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Glaucoma or ocular hypertension patients

Experimental group

Treatment:

Device: SENSIMED Triggerfish