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NCT03193736 Clinical Trial

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

Open Angle Glaucoma Clinical Trial

— STAR-I  

Official title:
A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03193736
Other study ID # ISM04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 19, 2017
Est. completion date November 25, 2019

Study information
Verified date February 2021
Source iSTAR Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date November 25, 2019
Est. primary completion date April 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MINIject implant
MINIject implant is used to reduce intra-ocular pressure (IOP) in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery.

Locations
Country Name City State
India Maxivision Eye Hospital Hyderabad Telangana
Panama Clinica de ojos Orillac-Calvo Panama city

Sponsors (1)
Lead Sponsor Collaborator
iSTAR Medical

Countries where clinical trial is conducted

India,  Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation Change of Medicated diurnal IOP [mmHg] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication 6 months after implantation surgery
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