Health TrialsbyHealthPanel

Feasibility Clinical Evaluation of the Calibreye System

ConditionGlaucoma, Open-Angle
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMyra Vision Inc.

About this trial

To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Open angle, pseudoexfoliative or pigmentary glaucoma

IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg

Visual field mean deviation score of -3dB or worse

Area of healthy, free and mobile conjunctiva in the target quadrant

Disqualifiers

Angle closure glaucoma

Congenital, neovascular or other secondary glaucomas

Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring > 3 months prior to the preoperative visit)

Previous glaucoma shunt/valve in the target quadrant

Trial design

Design model

Single group

Treatments tested in this trial

  • Calibreye System

    Device

    Implantation of a glaucoma device to reduce intraocular pressure

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Investigational Device ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intraocular Pressure

Percent change in IOP from baseline to the 12-month visit

Time frame
12 Months
2

Adverse Events

Number and percentage of subjects having any adverse event

Time frame
12 Months

Secondary outcomes

1

Glaucoma Medication Usage

Change in number of medications used compared to baseline

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Myra Vision Inc.

Lead sponsor

Source ClinicalTrials.gov
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