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MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996200
Recruitment Status : Active, not recruiting
First Posted : June 24, 2019
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
iSTAR Medical

Brief Summary:
Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Glaucoma Eye Device: MINIject CS627 implant Not Applicable

Detailed Description:

The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.

The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: MINIject SO627
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open, Multicentre Clinical Trial Analysing the Efficacy and Safety of Miniject (MINI SO627) in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications Using a Single Operator Delivery Tool
Actual Study Start Date : July 23, 2019
Actual Primary Completion Date : February 14, 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: MINIject CS627 implant
MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.
Device: MINIject CS627 implant

MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool.

The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.





Primary Outcome Measures :
  1. medicated diurnal IOP [ Time Frame: 6 months post surgery ]
    Change in medicated diurnal IOP



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
  • Grade 3 or grade 4 according to Shaffer Angle Grading System.
  • Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg < IOP < 35 mmHg in the study eye at baseline visit.

Exclusion Criteria:

  • Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
  • Neovascular glaucoma in the study eye.
  • Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
  • Prior glaucoma surgery in the study eye.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996200


Locations
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Colombia
Clinica Oftalmologica del Caribe
Barranquilla, Colombia
India
Maxivision Eye Hospital
Hyderabad, Telangana, India, 500034
Panama
Panama Eye Center
Panama City, Panama
Sponsors and Collaborators
iSTAR Medical
Investigators
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Study Director: Zubair Hussain iSTAR
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Responsible Party: iSTAR Medical
ClinicalTrials.gov Identifier: NCT03996200    
Other Study ID Numbers: STAR-III (ISM08)
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by iSTAR Medical:
glaucoma
medical device
MIGS
drainage device
eye
reduction IOP
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases