A multicentre registry study to capture data with respect to CyPass clinical experience (CYCLE)

Long-term safety, effectiveness and clinical experience of the CyPass glaucoma implant when used in the standard clinical environment: a multicentre registry study with retrospective and/or prospective data capture

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74288501

Enrollment

500

Registered

2010-06-17

Start date

2009-12-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Eye Diseases Glaucoma

Interventions

The total duration of the treatments was 12 months. Observations and assessments included best corrected visual acuity (BCVA, Snellen), tonometry, slit lamp exam and adverse event assessment.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Able to understand study requirements and willing to follow study instructions and provide written consent 2. Diagnosis of glaucoma in the study eye 3. At the preoperative visit, a mean medicated or unmedicated intraocular pressure (IOP) in the study eye of greater than or equal to 18 mmHg and less than or equal to 44 mmHg

Exclusion criteria

Exclusion criteria: 1. Diagnosis of acute angle closure, narrow angle, uveitic or neovascular glaucoma in the study eye 2. Diagnosis of normal tension glaucoma in the study eye

Design outcomes

Primary

Measure	Time frame
Safety outcomes: Incidence of intra-operative and post-operative adverse events	—

Secondary

Measure	Time frame
Effectiveness Outcomes: 1. Mean change in IOP from baseline to 1 month post-operatively, and beyond 2. Mean change in required glaucoma medications used from baseline to 1 month post-operatively, and beyond	—

Countries

Bulgaria, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026