GlaucomaNCT02554214
Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device
A study testing Glafkos drainage device in people with Glaucoma, run by Rheon Medical SA at 1 site in Switzerland.
Trial summary
This will be a prospective, descriptive, mono-center, non-comparative study. A sample of 30 patients who satisfy entry criteria is estimated to be appropriate to provide safety and performance data for this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Glafkos drainage device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2015to Sep 2017
- 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 glaucoma after failed previous 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 ocular hypertension 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.
- Distance Snellen best corrected visual acuity (BCVA) better than 0.6 in the fellow eye.
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- For the first three subjects the Snellen BCVA in the study eye should be 0.5 or less. In addition, the visual field defined by the Mean Defect (MD) shall be higher than 10 dB.
- 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.
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- Patient with retinal artery occlusion in the study eye.
- Patient with corneal opacifications 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 any sign of past or present uveitis (anterior/posterior).
- 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.
Switzerland1 site, 1 recruiting
- Recruiting
Montchoisi Clinic
Lausanne, Canton of Vaud, 1006
André Mermoud, Prof., +4121 619 37 42, amermoud@gsvn.ch
André Mermoud, Prof. MD.
About this study
This will be a prospective, descriptive, mono-center, non-comparative study. A sample of 30 patients who satisfy entry criteria is estimated to be appropriate to provide safety and performance data for this study.
The objectives of the study are to verify the performance and safety of the Glafkos adjustable glaucoma drainage device system. Performance will be measured assessing the possibility to adjust the intra-ocular pressure post-operatively. Safety will be measured by the incidence and severity of adverse events.
The Glafkos device will be implanted in combination with a seton tube. The implant is placed under a scleral flap, in a manner analogous to the ex-Press device (Alcon). The distal end of the draining tube is linked to a seton draining tube, which is linked to a plate placed under the extraocular muscles, creating a filtering space at the orbit (filtering bleb).
- Conditions
- Glaucoma
- Being tested
- Glafkos drainage device
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glafkos drainage deviceDevice
Also called eyeWatch
| Study group | Role | What they receive |
|---|---|---|
| Glafkos device | Experimental | Not described Receives: Device: Glafkos drainage device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of SADE per patient.
Measured: 24 months
IOP measurement
IOP reduced by ≥ 20% or IOP < 21 mmHg, and no IOP < 5 mmHg on two consecutive visits after 3 months.
Measured: 24 months
Secondary outcomes (7)
Comprehensive biomicroscopy examination
Anterior and posterior segments examination using a slit-lamp biomicroscope to evaluate the condition of the cornea (epithelium, stroma, endothelium), the anterior chamber, the iris, the lens, the irido-corneal angle (cf. gonioscopy outcome 9), the vitreous body, retinal and optic nerve anatomy (cf funduscopy outcome 7).
Measured: day 1, day 7, day 14, day 28, month 2, month 3, month 6, month 12, month 18 and month 24
Assessment of easiness of surgery by surgeon
scale: 0=very easy to 5=very difficult
Measured: day 0
Assessment of easiness of adjustment
scale: 0=very easy to 5=very difficult
Measured: for 24 months
Subjective refraction
Assessment of the subjective refraction based on trial and error asking using trial lenses to achieve the best corrected visual acuity
Measured: day 7, day 14, day 28, month 2, month 3, month 6, month 12, month 18 and month 24
Funduscopy evaluation
indirect funduscopy using a 90D lens to evaluate the optic nerve anatomy (cup to disk ratio measurement) and the retinal structures
Measured: day 7, day 14, day 28, month 2, month 3, month 6, month 12, month 18 and month 24
Snellen BCVA
Distance (6m) decimal visual acuity after best optical correction was provided
Measured: day 7, day 14, day 28, month 2, month 3, month 6, month 12, month 18 and month 24
gonioscopy assessment
Irido-corneal angle assessment using the Schaffer grading scale (1-4)
Measured: day 7 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
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 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rheon Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554214
- Sponsor's protocol ID
- 1007
- Status last verified
- Sep 2015
- First submitted
- 10 Sep 2015
- Last updated
- 18 Sep 2015
- Results posted
- No
Publications
Roy S, Mermoud A. Efficacy and Safety of an Adjustable Glaucoma Drainage Device (eyeWatch System) for Refractory Glaucoma: A 2-Year Prospective Study. J Glaucoma. 2024 Feb 1;33(2):132-138. doi: 10.1097/IJG.0000000000002334. Epub 2023 Nov 3.
PubMed 37974333
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device
- ClinicalTrials.gov ID
- NCT02554214
- Acronym / sponsor ID
- 1007
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rheon Medical SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- First posted
- 18 Sep 2015 (estimated)
- 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 will be a prospective, descriptive, mono-center, non-comparative study. A sample of 30 patients who satisfy entry criteria is estimated to be appropriate to provide safety and performance data for this study.
The objectives of the study are to verify the performance and safety of the Glafkos adjustable glaucoma drainage device system. Performance will be measured assessing the possibility to adjust the intra-ocular pressure post-operatively. Safety will be measured by the incidence and severity of adverse events.
The Glafkos device will be implanted in combination with a seton tube. The implant is placed under a scleral flap, in a manner analogous to the ex-Press device (Alcon). The distal end of the draining tube is linked to a seton draining tube, which is linked to a plate placed under the extraocular muscles, creating a filtering space at the orbit (filtering bleb).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glafkos device | Experimental | Device: Glafkos drainage device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient must be 18 years of age or older.
- Patient shall suffer from primary open angle glaucoma, pseudo-exfoliative glaucoma, or refractory glaucoma after failed previous 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 ocular hypertension 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 (15 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 |
|---|---|---|
| Glafkos drainage deviceAlso: eyeWatch | Device | Glafkos device |
Primary outcome
Number and type of SADE per patient.
Time frame: 24 months
IOP measurement
Time frame: 24 months
IOP reduced by ≥ 20% or IOP < 21 mmHg, and no IOP < 5 mmHg on two consecutive visits after 3 months.
7 secondary outcomes
Comprehensive biomicroscopy examination
Time frame: day 1, day 7, day 14, day 28, month 2, month 3, month 6, month 12, month 18 and month 24
Assessment of easiness of surgery by surgeon
Time frame: day 0
Assessment of easiness of adjustment
Time frame: for 24 months
Subjective refraction
Time frame: day 7, day 14, day 28, month 2, month 3, month 6, month 12, month 18 and month 24
Funduscopy evaluation
Time frame: day 7, day 14, day 28, month 2, month 3, month 6, month 12, month 18 and month 24
Snellen BCVA
Time frame: day 7, day 14, day 28, month 2, month 3, month 6, month 12, month 18 and month 24
gonioscopy assessment
Time frame: day 7 and day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
- Derived from this study: PubMed 37974333Roy S, Mermoud A. Efficacy and Safety of an Adjustable Glaucoma Drainage Device (eyeWatch System) for Refractory Glaucoma: A 2-Year Prospective Study. J Glaucoma. 2024 Feb 1;33(2):132-138. doi: 10.1097/IJG.0000000000002334. Epub 2023 Nov 3.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glafkos drainage device in people with Glaucoma, run by Rheon Medical SA at 1 site in Switzerland.
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 10 inclusion and 15 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 18 Sep 2015. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and type of SADE per patient. (time frame: 24 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?
On the ClinicalTrials.gov record for NCT02554214, 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 18 Sep 2015.