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

NCT ID: NCT06577857

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-04

Study Completion Date

2025-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Open Angle Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inferonasal MIMS Surgery Cohort

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

Inferonasal Minimally Invasive Micro Sclerostomy

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Inferonasal MIMS

Eligibility Criteria

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Inclusion Criteria

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

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanoculis Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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S. Malayan Eye Center

Yerevan, , Armenia

Site Status RECRUITING

Countries

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Armenia

Central Contacts

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Khan Lau, OD

Role: CONTACT

8082862666

Facility Contacts

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Lilit A Voskanyan, MD

Role: primary

+374-10-34-49-44

Other Identifiers

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MMS-EEU-8

Identifier Type: -

Identifier Source: org_study_id

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