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MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

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. Identifier: NCT03374553
Recruitment Status : Active, not recruiting
First Posted : December 15, 2017
Last Update Posted : August 21, 2020
Information provided by (Responsible Party):
iSTAR Medical

Brief Summary:

The study will evaluate the efficacy and safety of MINIject 636 and IOP lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Device: MINIject 636 implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open, Multicentre Clinical Trial Analysing the Effectiveness and Safety of MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Actual Study Start Date : November 25, 2017
Actual Primary Completion Date : January 17, 2019
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: MINIject 636 implant

MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention.

The intervention is to be performed as stand-alone surgery.

Device: MINIject 636 implant

MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.

The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach.

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

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

Inclusion Criteria:

  • Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
  • Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
  • Glaucoma not adequately controlled

Exclusion Criteria:

  • Diagnosis of glaucoma other than open angle glaucoma
  • Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
  • Neovascular glaucoma in the study eye
  • Prior glaucoma surgery in the study eye
  • Clinically significant corneal disease
  • Patients with poor vision

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 identifier (NCT number): NCT03374553

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Clínica Oftalmológica del Caribe
Barranquilla, Colombia
Maxivision Eye Hospital
Hyderabad, Telangana, India, 500034
Panama Eye Center
Panama city, Panama
Sponsors and Collaborators
iSTAR Medical
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Study Director: Zubair Hussain, PhD iSTAR Medical
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Responsible Party: iSTAR Medical Identifier: NCT03374553    
Other Study ID Numbers: ISM05
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 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
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases