NCT06614218

Brief Summary

This is a post-market clinical follow-up, retrospective chart review of MIMS® surgical procedures conducted during time period between Sep 2023 and May 2025.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

September 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

September 24, 2024

Last Update Submit

January 8, 2025

Conditions

Open Angle Glaucoma

Keywords

PolypharmacyIntraocular PressureMIMSMinimally Invasive Glaucoma SurgeryMIGSMTMTTrabeculectomySclerostomy

Outcome Measures

Primary Outcomes (3)

  • Change in IOP from medicated baseline at 12 months post-MIMS® surgery

    Medicated baseline at 12 months post-MIMS® surgery

  • Change in the number of topical IOP-lowering medications from medicated baseline at 12 months post-MIMS® surgery

    Medicated baseline at 12 months post-MIMS® surgery

  • Success rate at 12 months post-MIMS® surgery

    12 months post-MIMS® surgery

Study Arms (1)

MIMS Surgery Cohort

This cohort consists subjects treated with MIMS® Device as a standalone procedure during time period (27 Sep 2023 - 31 May 2025), and with documented post-operative follow-up available in the medical charts.

Device: Minimally Invasive Micro Sclerostomy

Interventions

Minimally Invasive Micro SclerostomyDEVICE

The MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the eye.

Also known as: MIMS
MIMS Surgery Cohort

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of subjects of Armenian descent that were treated with the MIMS® Device as a standalone procedure between 27 Sep 2023 and 30 April 2024.

You may qualify if:

  • Eye treated with MIMS® Device as a standalone procedure
  • MIMS® surgery was performed between 27 Sep 2023 and 30 April 2024

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S. Malayan Eye Center

Yerevan, Armenia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Central Study Contacts

Khan Lau, OD

CONTACT

8082862666khan@sanoculis.com

Study Design

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

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 26, 2024

Study Start

February 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations

AR(1)