Clinical trial NCT04524416: MINIject Global Long-Term Follow-up Study
Official title: A Prospective, Open, Multicentre Study Analysing the Long-term Safety of MINIject Glaucoma Implants in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Open Angle Glaucoma
Intra Ocular Pressure (IOP) reduction
Glaucoma Drainage Device
Minimally Invasive Glaucoma Surgery (MIGS)
Supraciliary space
Ocular hypertension
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2020-08-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with open-angle glaucoma not-controlled with hypotensive medications and who, to treat this condition, already received MINIject in a previous study

Brief summary: The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Detailed description: The study aims to assess long-term safety and performance of MINIject glaucoma implant up to 5 years post-implantation. Patients who received implant and were followed for 2 years in a previous study, will be invited to continue long-term follow-up from 2 to 5 years post-implantation at annual intervals. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Eligibility criteria: Inclusion Criteria:

* Patient who received a MINIject glaucoma implant within a prior clinical study
* Patient continues to have MINIject implanted at the point of enrolment
* Patient must provide written informed consent to participate

Exclusion Criteria:

* Individuals under tutorship or trusteeship
* Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol

Primary outcomes:
measure: Proportion of patients with serious device-related adverse event in study eye
timeFrame: 5 years post-implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Clinica Oftalmologica del Caribe
city: Grenoble
country: France
facility: Center Hospotalier Universitaire Genoble Alpes
city: Lyon
country: France
facility: Hopital de la Croix-Rousse
city: Köln
country: Germany
facility: Uniklinik Köln
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
state: Rheinland Pfalz
city: München
country: Germany
facility: Klinikum der Universität München
city: Hyderabad
country: India
facility: Maxivision Eye Hospital
state: Telangana
city: Panama City
country: Panama
facility: Panama Eye Center
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: iSTAR Medical
name: Zubair Hussain, PhD
role: STUDY_DIRECTOR
References: