NCT05159817

Brief Summary

The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 3, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

December 3, 2021

Last Update Submit

February 10, 2023

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • Assess post-op IOP reduction

    Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%

    12, 24 and 36 months

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655

You may qualify if:

  • All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655

You may not qualify if:

  • if cannot assist to all future follow-up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malayan Center

Yerevan, 0033, Armenia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Design

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

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 16, 2021

Study Start

December 15, 2021

Primary Completion

February 28, 2024

Study Completion

December 31, 2024

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)