Clinical trial NCT03114059: 5 Years Long Term Results After Standalone CyPass-Implantation
Official title: Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Late Effects of Surgery
Lead sponsor: Dietrich-Bonhoeffer-Klinikum
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 130 Patient with at least one treated eye

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
timeFrame: up to 7 years
measure: Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)
timeFrame: up to 7 years
measure: Number of Additional Medication
timeFrame: up to 7 years
measure: Number of Participants With Secondary Glaucoma Procedures
timeFrame: up to 7 years
Secondary outcomes:
measure: Number of Participants With Stability of Optic Nerve
timeFrame: up to 7 years
measure: Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness
timeFrame: up to 7 years
measure: Number of Participants With Stability of Visual Field
timeFrame: up to 7 years
measure: Number of Participants With Stability of Stent Position
timeFrame: up to 7 years
measure: Number of Participants With Stability of Stent Tissue Interaction
timeFrame: up to 7 years
measure: Number of Participants With Intra-and Postoperative Complications
timeFrame: up to 7 years
measure: Number of Participants With Suprachoroidal Bleb
timeFrame: up to 7 years
Other outcomes:
Locations:
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinikum
state: Mecklenburg/Vorpommern
Study officials:
affiliation: Department of Ophthalmology, Neubrandenburg, Germany
name: Helmut Hoeh, MD,FEBO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.