Aqueous Humor DrainageNCT05912790
eyeTube in Combination With the eyeWatch Implant
A study testing eyeTube in people with Aqueous Humor Drainage, run by Rheon Medical SA at 1 site in Senegal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aqueous Humor Drainage
- What is being tested?
- eyeTube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSenegal
- Study dates
- 6 Jun 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aqueous Humor Drainage
- Being tested
- eyeTube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eyeTubeDevice
Implantation of a drainage device in the eye, in combination with the eyeWatch implant
| Study group | Role | What they receive |
|---|---|---|
| Treated with the eyeTube | Experimental | Not described Receives: Device: eyeTube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP) reduction
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.
Measured: 12 months
Adverse events
The incidence and severity of adverse events in the study eye (overall and related to the eyeWatch system) throughout the follow-up period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start6 Jun 2023
- Primary completion20 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aqueous Humor DrainageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rheon Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912790
- Sponsor's protocol ID
- SEN-CL
- Status last verified
- Aug 2023
- First submitted
- 12 Jun 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eyeTube in Combination With the eyeWatch Implant
- ClinicalTrials.gov ID
- NCT05912790
- Acronym / sponsor ID
- SEN-CL
- Conditions
- Aqueous Humor Drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rheon Medical SAIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with the eyeTube | Experimental | Device: eyeTube |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - 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.
Key exclusion criteria (23 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eyeTubeImplantation of a drainage device in the eye, in combination with the eyeWatch implant | Device | Treated with the eyeTube |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eyeTube in people with Aqueous Humor Drainage, run by Rheon Medical SA at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (IOP) reduction (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.