Open Angle GlaucomaNCT03210571
Clinical Investigation of the eyeWatch Glaucoma Drainage Device
A study testing eyeWatch system in people with Open Angle Glaucoma, run by Rheon Medical SA at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- eyeWatch system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2018to 27 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Open Angle Glaucoma
- Being tested
- eyeWatch system
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eyeWatch systemDevice
Also called Adjustable glaucoma drainage device (AGDD)
The eyeWatch device is composed of an AGDD, a control unit and a draining plate
| Study group | Role | What they receive |
|---|---|---|
| eyeWatch device | Experimental | Not described Receives: Device: eyeWatch system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of serious adverse device events
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.
Measured: 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
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)
Measured: Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 May 2018
- Primary completion27 Oct 2020
- Study completion27 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies 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
- 27 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
- NCT03210571
- Sponsor's protocol ID
- 3007
- Status last verified
- Oct 2021
- First submitted
- 1 Jul 2017
- Last updated
- 28 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan
Publications
Villamarin A, Roy S, Bigler S, Stergiopulos N. A new adjustable glaucoma drainage device. Invest Ophthalmol Vis Sci. 2014 Mar 25;55(3):1848-52. doi: 10.1167/iovs.13-12626.
PubMed 24557347
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the eyeWatch Glaucoma Drainage Device
- ClinicalTrials.gov ID
- NCT03210571
- Acronym / sponsor ID
- 3007
- Conditions
- Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Rheon Medical SAIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 27 Oct 2020 (actual)
- First posted
- 7 Jul 2017 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eyeWatch device | Experimental | Device: eyeWatch system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| eyeWatch systemAlso: Adjustable glaucoma drainage device (AGDD)The eyeWatch device is composed of an AGDD, a control unit and a draining plate | Device | eyeWatch device |
Primary outcome
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Background: PubMed 24557347Villamarin A, Roy S, Bigler S, Stergiopulos N. A new adjustable glaucoma drainage device. Invest Ophthalmol Vis Sci. 2014 Mar 25;55(3):1848-52. doi: 10.1167/iovs.13-12626.
- Individual participant dataSharing planned: No. There is no plan
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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 eyeWatch system in people with Open Angle Glaucoma, run by Rheon Medical SA at 1 site in United Kingdom.
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 8 inclusion and 14 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: finished, as of the sponsor's last update on 28 Oct 2021. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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?
On the ClinicalTrials.gov record for NCT03210571, which also lists 1 linked publication.
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 28 Oct 2021.