5 Years Long Term Results After Standalone CyPass-Implantation

NCT03114059 | Completed Results

• 1 other identifier: STI 06/16
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma

Keywords

Late Effects of Surgery

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

  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

  up to 7 years

Secondary Outcomes (7)

• Number of Participants With Stability of Optic Nerve

  up to 7 years

• Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness

  up to 7 years

• Number of Participants With Stability of Visual Field

  up to 7 years

• Number of Participants With Stability of Stent Position

  up to 7 years

• Number of Participants With Stability of Stent Tissue Interaction

  up to 7 years

Study Arms (1)

standalone CyPass implantation

patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago

Diagnostic Test: Glaucoma diagnostics

Interventions

Glaucoma diagnostics DIAGNOSTIC_TEST

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

standalone CyPass implantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

130 Patient with at least one treated eye

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dietrich-Bonhoeffer-Klinikum: lead

Study Sites (1)

Dietrich-Bonhoeffer-Klinikum

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

Location

Related Publications (4)

• 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.

  PMID: 25304276 BACKGROUND

• 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.

  PMID: 25747677 BACKGROUND

• 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.

  PMID: 23958836 BACKGROUND

• 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.

  PMID: 24771171 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Ahmed Medra
• Organization: Dietrich-Bonhoeffer-Klinikum

a.medra@live.com

+49 395 775 13483

Study Officials

• Helmut Hoeh, MD,FEBO

  Department of Ophthalmology, Neubrandenburg, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 14, 2017
• Study Start: February 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: April 1, 2020
• Last Updated: July 14, 2022
• Results First Posted: July 14, 2022

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: results are planned to published in December 2020
• Access Criteria: Publication in ophthalmological journals provided and checked by Ahmed Medra

Locations

DE (1)