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Completed

NCT Number: NCT03114059

5 Years Long Term Results After Standalone CyPass-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

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Dietrich-Bonhoeffer-Klinikum

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glaucoma diagnostics

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Number of Participants With Stability of Optic Nerve

    Time frame: 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.

  2. Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness

    Time frame: 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.

  3. Number of Participants With Stability of Visual Field

    Time frame: 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.

  4. Number of Participants With Stability of Stent Position

    Time frame: 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

  5. Number of Participants With Stability of Stent Tissue Interaction

    Time frame: 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.

  6. Number of Participants With Intra-and Postoperative Complications

    Time frame: up to 7 years

    The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure

  7. Number of Participants With Suprachoroidal Bleb

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dietrich-Bonhoeffer-Klinikum

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Apr 14, 2017
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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