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Minimally Invasive Micro Sclerostomy First in Man Safety and Preliminary Performance Study

NCT02355990 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-11-30

No results posted yet for this study

Summary

The study objective is to demonstrate the safety of Minimally Invasive Micro Sclerostomy (MIMS) device for lowering elevated IOP in patients diagnosed with glaucoma.

Conditions

  • Primary Open Angle Glaucoma
  • Pigmentary Glaucoma
  • Pseudoexfoliative Glaucoma

Interventions

PROCEDURE

Minimally Invasive Micro Sclerostomy

Creation of a drainage channel of 50 - 100 microns (diameter) at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjuctival space).

Sponsors & Collaborators

  • Sanoculis Ltd

    lead INDUSTRY

Principal Investigators

  • Daniel Cotlear, MD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-01
Primary Completion
2019-01-01
Completion
2020-12-15

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355990 on ClinicalTrials.gov