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OpenTrials
Completed

NCT Number: NCT03193736

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

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.

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maxivision Eye Hospital, Hyderabad, Telangana, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MINIject implant

Device

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.

Primary outcomes

  1. Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation

    Time frame: 6 months after implantation surgery

    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

Sponsors and collaborators

Lead sponsor

iSTAR Medical

Industry

Registry information

Official study 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

Acronym: STAR-I

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 21, 2017
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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