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N/A N=26 Treatment

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

Open Angle Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT03193736 ↗
Enrolled (actual)
26
Serious AEs
7.7%
Results posted
Feb 2021
Primary outcome: Primary: Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation — -8.95 mmHg

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MINIject implant (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
iSTAR Medical
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation		 -8.95 —

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03193736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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