NCT06844292

Brief Summary

The study aims to investigate postoperative outcomes after two different MIGS implants (MINIject or Hydrus) in combination with cataract surgery for patients with glaucoma.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Mar 2025Mar 2031

First Submitted

Initial submission to the registry

February 6, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2027

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2031

Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

February 6, 2025

Last Update Submit

March 11, 2025

Conditions

GlaucomaCataract

Keywords

GlaucomaOpen-angle GlaucomaCataractMinimally Invasive Glaucoma Surgery (MIGS)Intraocular Pressure (IOP) Reduction

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure After Surgery

    Mean IOP in mmHg one year after glaucoma surgery

    Baseline visit to 1 year

Secondary Outcomes (15)

  • Intraocular Pressure at Other Follow-Up Time Points

    Baseline visit to 5 years

  • Anti-Hypertensive Medications Required

    Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5

  • Best Corrected Visual Acuity

    Baseline visit and week 1, month 1/3/6 and year 1/2/3/4/5

  • Complete Success

    Baseline visit and visit at month 3/6 and year 1/2/3/4/5

  • Qualified Success

    Baseline visit and visit at month 3/6 and year 1/2/3/4/5

  • +10 more secondary outcomes

Study Arms (2)

MINIject

ACTIVE COMPARATOR

MINIject with Cataract Surgery

Device: MINIject with Cataract Surgery

Hydrus Microstent

ACTIVE COMPARATOR

Hydrus Microstent with Cataract Surgery

Device: Hydrus Microstent with Cataract Surgery

Interventions

MINIject with Cataract SurgeryDEVICE

Patients will be randomized to receive either a MINIject implant or a Hydrus Microstunt in conjunction with cataract surgery. If randomized to MINIject, the device will be implanted into the supraciliary space with a minimally invasive ab interno approach. It is designed to be implanted with its head in the anterior chamber and its body in the supraciliary space, leading to improved natural uveoscleral outflow by directing aqueous humor from the anterior chamber to the sub-scleral space. Cataract surgery will be performed with phacoemulsification.

MINIject
Hydrus Microstent with Cataract SurgeryDEVICE

Patients will be randomized to receive either a Hydrus Microstunt or a MINIject implant in conjunction with cataract surgery. If randomized to Hydrus Microstent, the device will be implanted into Schlemm's canal through the trabecular meshwork in order to dilate and restore the natural aqueous outflow pathway through Schlemm's canal, leading to a reduction of intraocular pressure. Cataract surgery will be performed with phacoemulsification.

Hydrus Microstent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with glaucoma in which surgery is indicated to reach target intraocular pressure as well as lens opacities where CS is indicated
  • Clinically eligible for both surgeries
  • Subjects not anticipated to require any further surgery in the next 12 months
  • Patients' age \> 18 years

You may not qualify if:

  • Patients who do not want to make follow-ups at the department
  • Angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrome, Axenfeld-Rieger syndrome
  • Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation
  • Allergy to any drugs or substances required for the protocol
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Styria, 8010, Austria

RECRUITING

MeSH Terms

Conditions

GlaucomaCataractGlaucoma, Open-Angle

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ewald Lindner, Prof.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewald Lindner, Prof.

CONTACT

+4331638580810ewald.lindner@medunigraz.at

Lena M Haiden, MD

CONTACT

+4331638530798lena.haiden@medunigraz.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Device: Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS), either Hydrus Microstent or MINIject. The patients will be randomized (1:1) to each treatment/intervention arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 25, 2025

Study Start

March 3, 2025

Primary Completion (Estimated)

March 3, 2027

Study Completion (Estimated)

March 3, 2031

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

not necessary

Locations

AU(1)