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TerminatedNCT06577857Updated Oct 15, 2026

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

An observational study in Open Angle Glaucoma, sponsored by Sanoculis Ltd. Terminated at 1 site in Armenia. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Sanoculis Ltd · Observational

Why this study was terminated
The study was terminated following completion of the Week 24 visit. The Week 30 follow-up visit was canceled due to internal company reasons.
Updated Oct 15, 2026Now TerminatedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
40 Years to 85 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Open Angle Glaucoma

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Keywords

  • Intraocular Pressure
  • MIMS
  • Inferonasal
  • Minimally Invasive Glaucoma Surgery
  • Trabeculectomy
  • Sclerostomy
  • MIGS
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's enrollment of 44 is below the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Sanoculis Ltd is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
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.

Eligibility criteria

Inclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • Inferonasal MIMS Surgery Cohort

    Cohort that includes subjects that have undergone the MIMS® inferonasal surgery.

    Device: Inferonasal Minimally Invasive Micro Sclerostomy

Interventions

  • DeviceInferonasal Minimally Invasive Micro Sclerostomy

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

    Also known as: Inferonasal MIMS

06

What researchers measure

Primary outcomes

  1. Intraocular Pressure Change (Baseline to 24 months)

    Change in IOP from medicated baseline to 24 months post-MIMS® surgery

    Time frame: Baseline to 24 months post-MIMS® surgery

  2. Intraocular Pressure Change (Baseline to 30 months)

    Change in IOP from medicated baseline to 30 months post-MIMS® surgery

    Time frame: Baseline to 30 months post-MIMS® surgery

  3. Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)

    Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery

    Time frame: Medicated baseline to 24 months post-MIMS® surgery

  4. Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)

    Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery

    Time frame: Medicated baseline to 30 months post-MIMS® surgery

  5. Surgery Success Rate (24 months)

    Success rate 24 months post-MIMS® surgery

    Time frame: 24 months post-MIMS® surgery

  6. Surgery Success Rate (30 months)

    Success rate 30 months post-MIMS® surgery

    Time frame: 30 months post-MIMS® surgery

Secondary outcomes

  1. Postoperative Complication Safety Outcomes

    Late (greater than 12 months) postoperative complications

    Time frame: Baseline to 30 months post-MIMS® surgery

  2. Interventional Safety Outcomes

    Late (greater than 12 months) postoperative interventions

    Time frame: Baseline to 30 months post-MIMS® surgery

07

Study locations

1 site
  • S. Malayan Eye Center
    Yerevan, Armenia
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Terminated The study was terminated following completion of the Week 24 visit. The Week 30 follow-up visit was canceled due to internal company reasons.
changed Oct 15, 2026
Primary completion
Jun 30, 2025→Jan 30, 2025 (actual)
Oct 15, 2026
Study completion
Jun 30, 2025→Jan 30, 2025 (actual)
Oct 15, 2026
Enrollment
53 (estimated)→44 (actual)
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Recruiting→Terminated
    Why stopped The study was terminated following completion of the Week 24 visit. The Week 30 follow-up visit was canceled due to internal company reasons.
    Primary completion Jun 30, 2025→Jan 30, 2025 (now actual)
    Study completion Jun 30, 2025→Jan 30, 2025 (now actual)
    Enrollment 53 (estimated)→44 (actual)
    + 5 other changes: verification date, criteria formatting, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06577857
Lead sponsor
Sanoculis Ltd
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Nov 4, 2022
Primary completion
Jan 30, 2025
Completion
Jan 30, 2025
Last update
Oct 15, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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