Back to resultsMINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract (STAR-VI)
Primary Purpose
Primary Open-angle Glaucoma, Cataract
Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring Primary Open-angle Glaucoma (POAG), Cataract, Intra Ocular Pressure (IOP) reduction, Glaucoma Drainage Device, Minimally Invasive Glaucoma Surgery (MIGS), Supraciliary space, Combined procedure (POAG and phacoemulsification)
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of primary open angle glaucoma (POAG) in the study eye
- Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
- Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication
- Patient must provide written informed consent to participate
Exclusion Criteria:
- Known or suspected allergy or hypersensitivity to medical silicone
- Allergy to fluorescein
- Presence of silicone oil in the study eye
- Individuals under tutorship or trusteeship
- Patient has a condition such that his / her ability to provide personal informed consent is compromised
Sites / Locations
- Panama Eye Center
- Hospital Clínico San Carlos
- East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital
- Princess Alexandra Eye Pavilion
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Outcomes
Primary Outcome Measures
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05432245
Brief Title
MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
Acronym
STAR-VI
Official Title
A Prospective, Open, Multicenter Clinical Trial Evaluating the Efficacy and Safety of MINIject Combined With Cataract Surgery in Patients With POAG Uncontrolled by Topical Hypotensive Medications and Operable Age-related Cataract Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iSTAR Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.
Detailed Description
The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed.
Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma, Cataract
Keywords
Primary Open-angle Glaucoma (POAG), Cataract, Intra Ocular Pressure (IOP) reduction, Glaucoma Drainage Device, Minimally Invasive Glaucoma Surgery (MIGS), Supraciliary space, Combined procedure (POAG and phacoemulsification)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)
Intervention Description
The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.
Primary Outcome Measure Information:
Title
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP
Description
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary open angle glaucoma (POAG) in the study eye
Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication
Patient must provide written informed consent to participate
Exclusion Criteria:
Known or suspected allergy or hypersensitivity to medical silicone
Allergy to fluorescein
Presence of silicone oil in the study eye
Individuals under tutorship or trusteeship
Patient has a condition such that his / her ability to provide personal informed consent is compromised
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubair Hussain, PhD
Organizational Affiliation
iSTAR Medical
Official's Role
Study Director
Facility Information:
Facility Name
Panama Eye Center
City
Panama City
Country
Panama
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital
City
Colchester
State/Province
Essex
Country
United Kingdom
Facility Name
Princess Alexandra Eye Pavilion
City
Edinburgh
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
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