Clinical Investigation of the eyeWatch Glaucoma Drainage Device

October 26, 2021 updated by: Rheon Medical SA
This study aims to test a new medical device, called the eyeWatch, used in filtering surgery for the treatment of glaucoma. This medical device has the following property: it allows better control of intraocular pressure in the initial postoperative phase by adjusting aqueous flow going through the device. The target criteria for the study are defined as: keeping intraocular pressure in target range; reducing the number of anti-glaucoma drugs; evaluating the number and type of postoperative complications. So far, this device has been already tested on 20 patients in Switzerland.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must be 18 years of age or older.
  • Patient shall suffer from primary open angle glaucoma, pseudo-exfoliative glaucoma, or refractory POAG or PEXG after previous failed filtering surgery, in the study eye. Diagnosis is based on glaucomatous optic neuropathy, Shaffer angle greater than 2 as seen on gonioscopy, and visual field defect attributed to glaucoma.
  • Eye to be treated shall be phakic or pseudophakic with no other active ocular disease or disorder except for incipiens cataract. Prior ophthalmic surgery in the study eye shall have been performed more than 3 months before enrollment in this study.
  • Patient condition is indicated for primary and secondary filtration surgery.
  • Presence of elevated intraocular pressure defined as an intraocular corrected pressure (IOP) > 20 mmHg in the study eye, under maximally tolerated medications. The IOP level shall be obtained on 2 consecutive measurements (not taken on the same day) prior to surgery.
  • Optic neuropathy is exclusively attributed to glaucoma.
  • Patient agreed to sign the written inform consent prior to entering into the investigation.
  • Patient is able and willing to complete post-operative follow-up requirements.

Exclusion Criteria:

  • Diagnosis of neovascular glaucoma, congenital glaucoma.
  • History of previous intraocular surgery in the study eye referring to but not limited to extraocular muscles (strabismus), corneal transplant, retinal surgery.
  • Proliferative or severe non-proliferative retinopathy in either eye.
  • Congenital anomaly of the anterior chamber angle in the study eye.
  • Optic neuropathy other than glaucoma in the study eye.
  • Patient with retinal vein occlusion in the study eye.
  • Patient with retinal artery occlusion in the study eye.
  • Patient with corneal opacifications, endotheliopathy, or irregularities that may interfere with the optic nerve evaluation or the IOP measurements in the study eye.
  • Patient with a history of severe eye trauma in the study eye.
  • Patient with ocular malformations such as microphthalmia in the study eye.
  • Patient with concurrent inflammatory/infective eye disorder in the study eye.
  • Patient with severe systemic disease or disabling conditions such as chronic renal failure, post organ transplants.
  • Patient participating in another clinical trial or having participated in another clinical trial less than 3 months prior to entering into the investigation.
  • Patient is pregnant, breast-feeding or unable to make the decision to participate in a clinical investigation (e.g. mentally ill person, mentally handicapped person)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: eyeWatch device
Device: eyeWatch system
The eyeWatch device is composed of an AGDD, a control unit and a draining plate
Other Names:
  • Adjustable glaucoma drainage device (AGDD)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and type of serious adverse device events
Time Frame: Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline

Demonstration of safety. The number and type of serious adverse device event per patient will be measured.

Results of biomicroscopy, gonioscopy, pachymetry visual field and endothelial count will be compared to baseline.
Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline
Effectiveness in reducing the intraocular pressure
Time Frame: Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline
Demonstration of the performance. The intraocular pressure (IOP in mmHg) will be measured at different time points to show the effective reduction compared to baseline. IOP reduced by ≥ 20% or IOP < 21 mmHg, and no IOP < 5 mmHg on two consecutive visits after 1 month (included)
Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rheon Medical SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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