Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study

September 24, 2024 updated by: Sanoculis Ltd

Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure: Long-Term Follow-Up Extension Study

A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

53

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
        • Recruiting
        • S. Malayan Eye Center
        • Contact:
          • Lilit A Voskanyan, MD
          • Phone Number: +374-10-34-49-44

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 underwent the MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment.

Description

Inclusion Criteria:

1. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment

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
Inferonasal MIMS Surgery Cohort
Cohort that includes subjects that have undergone the MIMS® inferonasal surgery.
Device: Inferonasal Minimally Invasive Micro Sclerostomy
The Inferonasal MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the inferonasal quadrant of the eye.
Other Names:
  • Inferonasal MIMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure Change (Baseline to 24 months)
Time Frame: Baseline to 24 months post-MIMS® surgery
Change in IOP from medicated baseline to 24 months post-MIMS® surgery
Baseline to 24 months post-MIMS® surgery
Intraocular Pressure Change (Baseline to 30 months)
Time Frame: Baseline to 30 months post-MIMS® surgery
Change in IOP from medicated baseline to 30 months post-MIMS® surgery
Baseline to 30 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)
Time Frame: Medicated baseline to 24 months post-MIMS® surgery
Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery
Medicated baseline to 24 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)
Time Frame: Medicated baseline to 30 months post-MIMS® surgery
Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery
Medicated baseline to 30 months post-MIMS® surgery
Surgery Success Rate (24 months)
Time Frame: 24 months post-MIMS® surgery
Success rate 24 months post-MIMS® surgery
24 months post-MIMS® surgery
Surgery Success Rate (30 months)
Time Frame: 30 months post-MIMS® surgery
Success rate 30 months post-MIMS® surgery
30 months post-MIMS® surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complication Safety Outcomes
Time Frame: Baseline to 30 months post-MIMS® surgery
Late (greater than 12 months) postoperative complications
Baseline to 30 months post-MIMS® surgery
Interventional Safety Outcomes
Time Frame: Baseline to 30 months post-MIMS® surgery
Late (greater than 12 months) postoperative interventions
Baseline to 30 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 (Actual)

November 4, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMS-EEU-8

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.

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