Glaucoma
Conditions
Keywords
Late Effects of Surgery
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTGlaucoma diagnostics
Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination
Sponsors
Dietrich-Bonhoeffer-Klinikum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patients who have undergone a standalone cypass implantation at least 3 years ago * signed inform consent
Exclusion criteria
* Patients with too much travel distance between study center and home * Patients who cannot visit the studycenter due to health problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg | 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) | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stability of Stent Tissue Interaction | up to 7 years | 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. |
| Number of Participants With Stability of Optic Nerve | up to 7 years | 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. |
| Number of Participants With Suprachoroidal Bleb | up to 7 years | 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 |
| Number of Participants With Intra-and Postoperative Complications | up to 7 years | The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure |
| Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness | up to 7 years | 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. |
| Number of Participants With Stability of Visual Field | up to 7 years | 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. |
| Number of Participants With Stability of Stent Position | up to 7 years | 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 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standalone CyPass Implantation patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago | 230 |
| Total | 230 |
Baseline characteristics
| Characteristic | Standalone CyPass Implantation | — |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | — |
| Age, Categorical >=65 years | 165 Participants | — |
| Age, Categorical Between 18 and 65 years | 64 Participants | — |
| Age, Continuous | 69 years STANDARD_DEVIATION 12.095 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 230 participants | — |
| Sex: Female, Male Female | 119 Participants | — |
| Sex: Female, Male Male | 111 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 75 |
| other Total, other adverse events | 1 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standalone CyPass Implantation | Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination) | preoperative | 21.127 mmHg | Standard Deviation 7.831 |
| Standalone CyPass Implantation | Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination) | postoperative | 16.553 mmHg | Standard Deviation 6.633 |
| Standalone CyPass Implantation | Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination) | change | -4.697 mmHg | Standard Deviation 8.212 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standalone CyPass Implantation | Number of Additional Medication | preoperative | 1.813 numbers of active substances | Standard Deviation 1.182 |
| Standalone CyPass Implantation | Number of Additional Medication | postoperative | 2.014 numbers of active substances | Standard Deviation 1.053 |
| Standalone CyPass Implantation | Number of Additional Medication | change | 0.173 numbers of active substances | Standard Deviation 1.201 |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standalone CyPass Implantation | Number of Participants With Secondary Glaucoma Procedures | 83 Participants |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standalone CyPass Implantation | Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg | Target pressure achieved - without medication | 8 Participants |
| Standalone CyPass Implantation | Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg | Target pressure achieved - with medication | 45 Participants |
| Standalone CyPass Implantation | Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg | Target pressure not achieved | 22 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | resistance during implantation | 1 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | heavy bleeding (intraoperative) | 6 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | bad stent positioning | 5 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | increase in pressure: early postoperative | 5 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | increase in pressure | 25 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | increase in pressure: glaucomatous attack | 17 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | hyphema | 4 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | hypotonia | 3 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | early contact to the endothelium | 2 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | age-related macula degeneration | 4 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | gliosis | 2 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | macula edema | 1 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | keratitis | 1 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | dry eyes symptoms | 5 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | fibrin | 2 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | stroke | 1 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | uveitis | 1 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | cataract progression | 15 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | secondary cataract | 5 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | lid tumor | 1 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | pain during operation | 3 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | recurrent neuritis | 1 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | retroiridal cyst | 1 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | total number of complications | 111 Participants |
| Standalone CyPass Implantation | Number of Participants With Intra-and Postoperative Complications | total number of affected eyes | 105 Participants |
Secondary
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
Population: for 7 eyes this examination was not done due to low compliance
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standalone CyPass Implantation | Number of Participants With Stability of Optic Nerve | stable | 52 Participants |
| Standalone CyPass Implantation | Number of Participants With Stability of Optic Nerve | not stable | 16 Participants |
Secondary
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
Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The discrepancy is caused by insufficient cooperation (due to old age or poor general condition) of individual participants to carry out this examination to the end
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standalone CyPass Implantation | Number of Participants With Stability of Stent Position | Stent is stable | 43 Participants |
| Standalone CyPass Implantation | Number of Participants With Stability of Stent Position | Stent moves deeper | 12 Participants |
| Standalone CyPass Implantation | Number of Participants With Stability of Stent Position | Stent emerges | 13 Participants |
Secondary
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
Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The discrepancy is caused by insufficient cooperation (due to old age or poor general condition) of individual participants to carry out this examination to the end
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standalone CyPass Implantation | Number of Participants With Stability of Stent Tissue Interaction | stable | 24 Participants |
| Standalone CyPass Implantation | Number of Participants With Stability of Stent Tissue Interaction | slight adhesions | 32 Participants |
| Standalone CyPass Implantation | Number of Participants With Stability of Stent Tissue Interaction | severe adhesions | 18 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standalone CyPass Implantation | Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness | stable | 40 Participants |
| Standalone CyPass Implantation | Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness | worsening | 35 Participants |
Secondary
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
Population: The Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The discrepancy is caused by insufficient cooperation (due to old age or poor general condition) of individual participants to carry out this examination to the end
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standalone CyPass Implantation | Number of Participants With Stability of Visual Field | improvement | 11 Participants |
| Standalone CyPass Implantation | Number of Participants With Stability of Visual Field | stable | 49 Participants |
| Standalone CyPass Implantation | Number of Participants With Stability of Visual Field | progression | 13 Participants |
Secondary
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
Population: for 12 eyes this examination was not done due to low compliance
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standalone CyPass Implantation | Number of Participants With Suprachoroidal Bleb | big | 2 Participants |
| Standalone CyPass Implantation | Number of Participants With Suprachoroidal Bleb | none | 44 Participants |
| Standalone CyPass Implantation | Number of Participants With Suprachoroidal Bleb | small | 17 Participants |