eyeTube in Combination With the eyeWatch Implant

August 29, 2023 updated by: Rheon Medical SA
In this study, the investigators want to investigate the success of aqueous humor shunting in the retrobulbar space, using the eyeTube in combination with the eyeWatch implant. The investigators postulate that posterior aqueous humor shunting would be more effective, as this space offers a larger drainage area and a less aggressive local inflammatory environment than the subconjunctival space close to the limbus, resulting in lower and better-sustained IOP than in the more limited, fibroblast-promoting subconjunctival environment surrounding standard implants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.
15

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

  • Senegal
      • Mbour, Senegal
        • Senghor Centre

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - Men and women aged 18 to 85.
  • Diagnosis of primary open-angle glaucoma meeting both of the following criteria:
  • IOP uncontrolled by at least one (1) or more classes of topical IOP-lowering medical therapy, and
  • Failure of at least one (1) conventional intraocular glaucoma surgery (e.g., glaucoma filter surgery or tube shunting) or cilioablative procedures (e.g., cryotherapy, cyclodiode therapy).
  • Trabecular meshwork visible on gonioscopy, with a Shaffer angle ≥ 3 in the target quadrant.
  • Patients must be able to understand the study requirements and provide written informed consent.
  • Patients must be willing to follow study instructions, agree to comply with all study procedures and be able to attend all scheduled follow-up examinations for at least 12 months after surgery.

Exclusion Criteria:

  • - Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breast-feeding, inability to understand or give informed consent.
  • Choroidal detachment, choroidal effusion or any active choroidopathy.
  • Diagnosis of acute angle-closure glaucoma or malignant glaucoma.
  • History of glaucoma drainage/valve implant in target quadrant
  • Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathology (e.g. pterygium) in the target quadrant.
  • Use of systemic (oral or intravenous) glaucoma medications
  • History of corneal surgery (including LASIK and PRK), corneal opacities, corneal diseases or any corneal pathology likely to interfere with IOP measurement.
  • Eyes with ocular malformations such as microphthalmia
  • Eyes with concomitant inflammatory/infectious ocular disorders
  • Aphakia
  • Presence of an anterior chamber intraocular lens or implantable contact lens
  • Previous complicated cataract surgery or presence of vitreous in the anterior chamber
  • Cataract surgery performed less than 6 months before the start of the study
  • Presence of intraocular silicone oil
  • Previous diagnosis of chronic uveitis in either eye
  • Active diabetic retinopathy, choroidal neovascularization, secondary retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy or other ophthalmic disease or disorder likely to distort study results.
  • Impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
  • Uncontrolled systemic disease (e.g. diabetes, hypertension)
  • History of dermatological keloid formation
  • Use of ocular or systemic steroids in the last 30 days (chronic continuous use of systemic steroids is permitted) prior to the screening visit, or known response to corticosteroids.
  • Pregnant or breast-feeding women, or women of childbearing age who do not wish to use medically acceptable contraception between the screening visit and the 12-month follow-up visit.
  • Known or suspected allergy or hypersensitivity to any component of the device (e.g. silicone).
  • Current participation or participation within the last 30 days (from the screening visit) in another clinical trial of an investigational drug or interventional device.

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: Treated with the eyeTube
Device: eyeTube
Implantation of a drainage device in the eye, in combination with the eyeWatch implant

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
Adverse events
Time Frame: 12 months
The incidence and severity of adverse events in the study eye (overall and related to the eyeWatch system) throughout the follow-up period.
12 months
Intraocular pressure (IOP) reduction
Time Frame: 12 months
The proportion of subjects achieving a mean reduction in IOP of ≥ 20% compared with pre-operative pressure at 12 months with the same or fewer hypotensive drugs.
12 months

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

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.
June 6, 2023

Primary Completion (Estimated)

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.
June 20, 2024

Study Completion (Estimated)

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.
September 30, 2024

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).
June 12, 2023

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.
June 12, 2023

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.
June 22, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
August 31, 2023

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.
August 29, 2023

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.
August 1, 2023

More Information

Terms related to this study

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.
  • SEN-CL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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