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

Sanoculis Ltd53 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Open Angle Glaucoma

Interventions

Inferonasal Minimally Invasive Micro SclerostomyDEVICE

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

S. Malayan Eye Center

Yerevan, Armenia

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

Surgery Success Rate (24 months)

Success rate 24 months post-MIMS® surgery

Time frame: 24 months post-MIMS® surgery

Surgery Success Rate (30 months)

Success rate 30 months post-MIMS® surgery

Time frame: 30 months post-MIMS® surgery

Secondary Outcomes

Postoperative Complication Safety Outcomes

Late (greater than 12 months) postoperative complications

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

Central Contacts

Khan Lau, OD

CONTACT

8082862666 khan@sanoculis.com

Data from ClinicalTrials.gov

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