NCT02228577

Brief Summary

This is a retrospective chart review of cases in which the CyPass Micro-Stent was implanted using the Model 241 Applier. The objective of this study is to characterize and evaluate the safety of the Model 241 Applier when used for CyPass Micro-Stent implantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 15, 2023

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

August 27, 2014

Last Update Submit

November 13, 2023

Conditions

Open Angle Glaucoma (OAG)

Outcome Measures

Primary Outcomes (1)

  • Ocular adverse events in the study eye

    Intraoperatively though the first 3 postoperative months

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with OAG who underwent combination cataract/glaucoma surgery and received the CyPass Micro-Stent using the CyPass Applier Model 241

You may qualify if:

  • Diagnosis of OAG
  • CyPass Micro-Stent implantation (using the CyPass system 241) following uncomplicated phacoemulsification cataract removal and intraocular lens implantation

You may not qualify if:

  • Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
  • Prior incisional glaucoma surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum

Neubrandenburg, Germany

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2014

First Posted

August 29, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 15, 2023

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)