An observational study in Glaucoma, sponsored by Dietrich-Bonhoeffer-Klinikum. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2022-07-14.
Sponsored by Dietrich-Bonhoeffer-Klinikum · Observational
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
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.
130 Patient with at least one treated eye
Exclusion Criteria:
patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Diagnostic Test: Glaucoma diagnostics
Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 7 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: up to 7 years
| Milestone | Standalone CyPass Implantation |
|---|---|
| Started | 230 |
| Completed | 230 |
| Not completed | 0 |
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.
| Participants | Standalone CyPass Implantation |
|---|---|
| Target pressure achieved - without medication | 8 |
| Target pressure achieved - with medication | 45 |
| Target pressure not achieved | 22 |
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
| mmHg | Standalone CyPass Implantation |
|---|---|
| preoperative | 21.127 ± 7.831 |
| postoperative | 16.553 ± 6.633 |
| change | -4.697 ± 8.212 |
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
| numbers of active substances | Standalone CyPass Implantation |
|---|---|
| preoperative | 1.813 ± 1.182 |
| postoperative | 2.014 ± 1.053 |
| change | 0.173 ± 1.201 |
To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented
| Participants | Standalone CyPass Implantation |
|---|---|
| Number of Participants With Secondary Glaucoma Procedures | 83 |
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.
| Participants | Standalone CyPass Implantation |
|---|---|
| stable | 52 |
| not stable | 16 |
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.
| Participants | Standalone CyPass Implantation |
|---|---|
| stable | 40 |
| worsening | 35 |
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.
| Participants | Standalone CyPass Implantation |
|---|---|
| improvement | 11 |
| stable | 49 |
| progression | 13 |
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
| Participants | Standalone CyPass Implantation |
|---|---|
| Stent is stable | 43 |
| Stent moves deeper | 12 |
| Stent emerges | 13 |
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.
| Participants | Standalone CyPass Implantation |
|---|---|
| stable | 24 |
| slight adhesions | 32 |
| severe adhesions | 18 |
The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure
| Participants | Standalone CyPass Implantation |
|---|---|
| resistance during implantation | 1 |
| heavy bleeding (intraoperative) | 6 |
| bad stent positioning | 5 |
| increase in pressure: early postoperative | 5 |
| increase in pressure | 25 |
| increase in pressure: glaucomatous attack | 17 |
| hyphema | 4 |
| hypotonia | 3 |
| early contact to the endothelium | 2 |
| age-related macula degeneration | 4 |
| gliosis | 2 |
| macula edema | 1 |
| keratitis | 1 |
| dry eyes symptoms | 5 |
| fibrin | 2 |
| stroke | 1 |
| uveitis | 1 |
| cataract progression | 15 |
| secondary cataract | 5 |
| lid tumor | 1 |
| pain during operation | 3 |
| recurrent neuritis | 1 |
| retroiridal cyst | 1 |
| total number of complications | 111 |
| total number of affected eyes | 105 |
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
| Participants | Standalone CyPass Implantation |
|---|---|
| none | 44 |
| small | 17 |
| big | 2 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standalone CyPass Implantation | 0/75 (0%) | 0/75 (0%) | 1/75 (1.3%) |
| Event | Standalone CyPass Implantation |
|---|---|
| Allergic reactionEye disorders | 1/75 |
all patients that undergone a standalone Cypass-implantation
| Age, Categorical(Participants) | Standalone CyPass Implantation |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 64 |
| >=65 years | 165 |
| Age, Continuous(years) | Standalone CyPass Implantation |
|---|---|
| Mean | 69 ± 12.095 |
| Sex: Female, Male(Participants) | Standalone CyPass Implantation |
|---|---|
| Female | 119 |
| Male | 111 |
| Race and Ethnicity Not Collected(Participants) | Standalone CyPass Implantation |
|---|
| Region of Enrollment(participants) | Standalone CyPass Implantation |
|---|---|
| Germany | 230 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — results will be published in ophthalmological journals
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