GlaucomaNCT03114059

5 Years Long Term Results After Standalone CyPass-Implantation

An observational study of Glaucoma, run by Dietrich-Bonhoeffer-Klinikum at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Glaucoma
What is being tested?: Glaucoma diagnostics
How many people: 230 participants
Where: 1 siteGermany
Study dates: 1 Feb 2017to 1 Apr 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 130 Patient with at least one treated eye

Who may be able to join

patients who have undergone a standalone cypass implantation at least 3 years ago
signed inform consent

Who cannot join

Patients with too much travel distance between study center and home
Patients who cannot visit the studycenter due to health problems

Trial locations and contacts

1 site in 1 country.

Germany1 site

Dietrich-Bonhoeffer-Klinikum
Neubrandenburg, Mecklenburg-Vorpommern, 17036

Other trials in Germany

About this study

Official title: Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation

This study evaluates the results of all clinically relevant findings of glaucoma diagnostics 5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent procedure. The comparison of Preoperative and long term postoperative results is the aim of this study to evaluate this young procedure of Glaucoma surgery

Read the detailed description

This is a post market study without interventions.The participants have been treated with CyPass-Stent implantation between 3 and 7 years ago to control the intraocular pressure . They will be invited for only one follow up visit to determine the present glaucoma status again, to determine the long term safety and effectiveness of the cypass stent procedure and to see whether addition therapy or surgical intervention is necessary.

Conditions: Glaucoma
Being tested: Glaucoma diagnostics
Keywords: Late Effects of Surgery
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Glaucoma diagnosticsDiagnostic test
Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination

Study groups in NCT03114059
Study group	Role	What they receive
standalone CyPass implantation		patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago Receives: Diagnostic Test: Glaucoma diagnostics

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
The Measurement of the intraocular Pressure is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative target pressure of 15 mmHg, 18 mmHg or 21 mmHg (depends on Glaucoma Status) has to be achieved.
Measured: up to 7 years
Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)
The Measurement of the intraocular Pressure change is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative pressure after 5 to 7 years has to be compared with the preoperative intraocular pressure (in mmHg)
The change was calculated only from two time points. (value at the final examination time point minus the value at the preoperative time point
Measured: up to 7 years
Number of Additional Medication
The number of additional Glaucoma medication is another criterion to determine the Efficacy of CyPass Stent Procedure (success rate). Up to 4 different active substance can be used to reduce the pressure. The more substances the patient uses postoperatively the lower is the success after implantation of the CyPass-Stent.
The postoperative number of medications after 5 years has to be compared with the preoperative number
Measured: up to 7 years
Number of Participants With Secondary Glaucoma Procedures
To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented
Measured: up to 7 years

Secondary outcomes (7)

Number of Participants With Stability of Optic Nerve
The Measurement of the optic nerve (HRT) in comparison to the baseline is needed to evaluate the glaucoma damage and to determine the Longterm success rate and the safety of the CyPass- Stent-Procedure.
With papillary tomography you can see the changes in the optic nerve head concerning the permanent failures of retinal vessels , measure them very precisely and compare them with the previous findings.
Measured: up to 7 years
Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness
The comparison of the preoperative and postoperative Status of the Retinal Nerve Fiber Layer Thickness and retinal fundus thickness is another criterion to determine the absolute and relative success.
Measured: up to 7 years
Number of Participants With Stability of Visual Field
The parameter of the Visual Field (Mean Deviation) will be measured to evaluate the Safety of the CyPass-Procedure. The visual Field shows the progression of glaucoma defects concerning failures in different parts for example in the center or in the periphery of the visual field.
Measured: up to 7 years
Number of Participants With Stability of Stent Position
Determination of Stent Position in the angle will be performed to exclude moving of the Stent. The stent could change it's position forward into the anterior chamber or backwards in the suprachorioidal space
Measured: up to 7 years
Number of Participants With Stability of Stent Tissue Interaction
Determination of iris tissue reaction to the stent will be performed. We document slight reaction without involving the opening, iris reaction with involving the opening and complete closure by tissue. The iris Tissue could overgrow the opening of the stent and therfore the function of the stent is disturbed or even failed.
Measured: up to 7 years
Number of Participants With Intra-and Postoperative Complications
The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure
Measured: up to 7 years
Number of Participants With Suprachoroidal Bleb
The Determination of the suprachoroidal bleb is needed to evaluate the function of the stent and the efficacy of the procedure. The bigger the bleb, the lower the pressure and the better the efficacy of the stent
Measured: up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20171 Apr 2020

First posted14 Apr 2017
Study start1 Feb 2017
Primary completion28 Feb 2018
Study completion1 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03114059
Sponsor's protocol ID: STI 06/16
Status last verified: Aug 2018
First submitted: 4 Apr 2017
Last updated: 14 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: results will be published in ophthalmological journals

Publications

Hoeh H, Vold SD, Ahmed IK, Anton A, Rau M, Singh K, Chang DF, Shingleton BJ, Ianchulev T. Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent. J Glaucoma. 2016 Jan;25(1):106-12. doi: 10.1097/IJG.0000000000000134.
PubMed 25304276
Garcia-Feijoo J, Rau M, Grisanti S, Grisanti S, Hoh H, Erb C, Guguchkova P, Ahmed I, Grabner G, Reitsamer H, Shaarawy T, Ianchulev T. Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study. Am J Ophthalmol. 2015 Jun;159(6):1075-1081.e1. doi: 10.1016/j.ajo.2015.02.018. Epub 2015 Mar 3.
PubMed 25747677
Grisanti S, Margolina E, Hoeh H, Rau M, Erb C, Kersten-Gomez I, Dick HB, Grisanti S. [Supraciliary microstent for open-angle glaucoma: clinical results of a prospective multicenter study]. Ophthalmologe. 2014 Jun;111(6):548-52. doi: 10.1007/s00347-013-2927-6. German.
PubMed 23958836
Hoh H, Grisanti S, Grisanti S, Rau M, Ianchulev S. Two-year clinical experience with the CyPass micro-stent: safety and surgical outcomes of a novel supraciliary micro-stent. Klin Monbl Augenheilkd. 2014 Apr;231(4):377-81. doi: 10.1055/s-0034-1368214. Epub 2014 Apr 25.
PubMed 24771171

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation
ClinicalTrials.gov ID: NCT03114059
Acronym / sponsor ID: STI 06/16
Conditions: Glaucoma
Keywords: Late Effects of Surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: Dietrich-Bonhoeffer-KlinikumIndustry (pharma, biotech, devices)
Study start: 1 Feb 2017 (actual)
Primary completion: 28 Feb 2018 (actual)
Study completion: 1 Apr 2020 (actual)
First posted: 14 Apr 2017 (actual)
Results: Posted 14 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
standalone CyPass implantation	–	Diagnostic Test: Glaucoma diagnosticspatients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 130 Patient with at least one treated eye

Key inclusion criteria (2 listed)

patients who have undergone a standalone cypass implantation at least 3 years ago
signed inform consent

Key exclusion criteria (2 listed)

Patients with too much travel distance between study center and home
Patients who cannot visit the studycenter due to health problems

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
Glaucoma diagnosticsHeidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination	Diagnostic test	standalone CyPass implantation

Primary outcome

Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
Time frame: up to 7 years
The Measurement of the intraocular Pressure is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative target pressure of 15 mmHg, 18 mmHg or 21 mmHg (depends on Glaucoma Status) has to be achieved.
Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)
Time frame: up to 7 years
The Measurement of the intraocular Pressure change is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative pressure after 5 to 7 years has to be compared with the preoperative intraocular pressure (in mmHg) The change was calculated only from two time points. (value at the final examination time point minus the value at the preoperative time point
Number of Additional Medication
Time frame: up to 7 years
The number of additional Glaucoma medication is another criterion to determine the Efficacy of CyPass Stent Procedure (success rate). Up to 4 different active substance can be used to reduce the pressure. The more substances the patient uses postoperatively the lower is the success after implantation of the CyPass-Stent. The postoperative number of medications after 5 years has to be compared with the preoperative number
Number of Participants With Secondary Glaucoma Procedures
Time frame: up to 7 years
To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented

7 secondary outcomes

Number of Participants With Stability of Optic Nerve
Time frame: up to 7 years
Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness
Time frame: up to 7 years
Number of Participants With Stability of Visual Field
Time frame: up to 7 years
Number of Participants With Stability of Stent Position
Time frame: up to 7 years
Number of Participants With Stability of Stent Tissue Interaction
Time frame: up to 7 years
Number of Participants With Intra-and Postoperative Complications
Time frame: up to 7 years
Number of Participants With Suprachoroidal Bleb
Time frame: up to 7 years

Results and safety

Results posted to the registry on 14 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standalone CyPass Implantation	230	230

Primary outcome: Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg

Time frame: up to 7 years. Count of participants. Unit: Participants

Measure	Standalone CyPass Implantation n = 75
Target pressure achieved - without medication	8
Target pressure achieved - with medication	45
Target pressure not achieved	22

Population analysed: only 75 study patients were able to visit the clinic and to undergone the 5 year examination, therefore we only could analyse the data of theses75 patients. The number of 230 Patients discribes all patients that fullfil the inclusion criteria.

Primary outcome: Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)

Time frame: up to 7 years. Mean (Standard Deviation). Unit: mmHg

Measure	Standalone CyPass Implantation n = 75
preoperative	21.127 (7.831)
postoperative	16.553 (6.633)
change	-4.697 (8.212)

Primary outcome: Number of Additional Medication

Time frame: up to 7 years. Mean (Standard Deviation). Unit: numbers of active substances

Measure	Standalone CyPass Implantation n = 75
preoperative	1.813 (1.182)
postoperative	2.014 (1.053)
change	0.173 (1.201)

Primary outcome: Number of Participants With Secondary Glaucoma Procedures

Time frame: up to 7 years. Count of participants. Unit: Participants

Measure	Standalone CyPass Implantation n = 230
Value	83

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standalone CyPass Implantation	0 of 75 (0%)	1 of 75 (1.3%)	0 of 75

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25304276Hoeh H, Vold SD, Ahmed IK, Anton A, Rau M, Singh K, Chang DF, Shingleton BJ, Ianchulev T. Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent. J Glaucoma. 2016 Jan;25(1):106-12. doi: 10.1097/IJG.0000000000000134.
Background: PubMed 25747677Garcia-Feijoo J, Rau M, Grisanti S, Grisanti S, Hoh H, Erb C, Guguchkova P, Ahmed I, Grabner G, Reitsamer H, Shaarawy T, Ianchulev T. Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study. Am J Ophthalmol. 2015 Jun;159(6):1075-1081.e1. doi: 10.1016/j.ajo.2015.02.018. Epub 2015 Mar 3.
Background: PubMed 23958836Grisanti S, Margolina E, Hoeh H, Rau M, Erb C, Kersten-Gomez I, Dick HB, Grisanti S. [Supraciliary microstent for open-angle glaucoma: clinical results of a prospective multicenter study]. Ophthalmologe. 2014 Jun;111(6):548-52. doi: 10.1007/s00347-013-2927-6. German.
Background: PubMed 24771171Hoh H, Grisanti S, Grisanti S, Rau M, Ianchulev S. Two-year clinical experience with the CyPass micro-stent: safety and surgical outcomes of a novel supraciliary micro-stent. Klin Monbl Augenheilkd. 2014 Apr;231(4):377-81. doi: 10.1055/s-0034-1368214. Epub 2014 Apr 25.
Individual participant dataSharing planned: Yes. results will be published in ophthalmological journals

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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.

Helmut Hoeh, MD,FEBO principal investigator

Department of Ophthalmology, Neubrandenburg, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Dietrich-Bonhoeffer-Klinikum at 1 site in Germany.

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 2 inclusion and 2 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 14 Jul 2022. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 14 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 of Patients That Achieve Target Intraocular Pressure Measured in mmHg (time frame: up to 7 years). The study lists 4 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 NCT03114059, which also lists 4 linked publications.

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 14 Jul 2022.