MIMS® Retrospective Chart Review

January 8, 2025 updated by: Sanoculis Ltd

Minimally Invasive Micro Sclerostomy (MIMS®) Retrospective Chart Review

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Armenia
      • Yerevan, Armenia
        • S. Malayan Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
The MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the eye.
Other Names:
  • MIMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in IOP from medicated baseline at 12 months post-MIMS® surgery
Time Frame: 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
Time Frame: Medicated baseline at 12 months post-MIMS® surgery
Medicated baseline at 12 months post-MIMS® surgery
Success rate at 12 months post-MIMS® surgery
Time Frame: 12 months post-MIMS® surgery
12 months post-MIMS® surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanoculis Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMS-EEU-9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open Angle Glaucoma

Clinical Trials on Minimally Invasive Micro Sclerostomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe