MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
STAR-VI
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
1 other identifier
interventional
30
3 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedStudy Start
First participant enrolled
January 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedFebruary 28, 2025
February 1, 2025
2.5 years
June 16, 2022
February 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Study Arms (1)
Treatment group
EXPERIMENTALInterventions
The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iSTAR Medicallead
Study Sites (4)
Panama Eye Center
Panama City, Panama
Hospital Clínico San Carlos
Madrid, Spain
East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital
Colchester, Essex, United Kingdom
Princess Alexandra Eye Pavilion
Edinburgh, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zubair Hussain, PhD
iSTAR Medical
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2022
First Posted
June 27, 2022
Study Start
January 18, 2023
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
February 28, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share