CClinicalTrials.gg
Sign In
TerminatedNCT05583591Updated Nov 1, 2024

Combined Phacoemulsification With iStent Inject W Versus Hydrus for Mild to Moderate Open Angle Glaucoma

An interventional study of Combined cataract surgery with Hydrus microstent and Combined cataract surgery with iStent Inject W in Open Angle Glaucoma, sponsored by Diablo Eye Associates. Terminated at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-01.

Sponsored by Diablo Eye Associates · Not applicable, Interventional, and Treatment

Why this study was terminated
Slow enrollment, sites unable to obtain iStent Inject W from manufacturer

From the registry’s dates

  • Primary completion was Apr 2024, 2 years 5 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

The goal of the study is to prospectively evaluate and compare Hydrus microstent to the iStent Inject Wide in combination with cataract surgery in patients with mild to moderate open angle glaucoma. Hydrus and iStent are the two FDA approved trabecular meshwork targeting microstents to treat open angle glaucoma in conjunction with cataract surgery.

02

Conditions studied

  • Open Angle Glaucoma

Keywords

  • Primary Open Angle Glaucoma
  • Hydrus
  • iStent
  • minimally invasive glaucoma surgery
  • MIGS
  • randomized
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 58 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

This is the only study on the registry with Diablo Eye Associates as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • >60 years or older
  • Visually significant cataract
  • Mild to moderate primary open angle glaucoma controlled on medications
  • undergoing cataract surgery with lens implantation and concurrent microstent placement
  • IOP ≥ 21 mmHg and ≤ 36 mmHg after washout of ocular hypotensive medication(s)
  • CCT 480 to 620μm
  • No prior ocular surgery including corneal refractive surgery
  • No SLT within 6 months of baseline visit, no history of intracameral glaucoma drug eluting implants
  • Visual field mean deviation ≤ -12 dB
  • Optic nerve abnormalities consistent with glaucoma, C/D ratio less than ≤0.8

Exclusion criteria

Exclusion Criteria:

  • Prior intraocular surgery
  • Visual field MD ≥ -12 dB
  • secondary glaucoma including uveitis, traumatic, malignant, neovascular, and congenital glaucoma.
  • Glaucoma related to elevated episcleral venous pressure including Sturge-Weber syndrome, thyroid eye disease, orbital tumor, and etc.
  • Uncontrolled intraocular pressure on maximum tolerated medical therapy;
  • Unable to perform wash-out IOP
  • Anatomic exclusion of narrow anterior chamber angle (Shaffer grade I-II), other angle abnormalities including angle closure glaucoma
  • Corneal disease or dystrophy
  • Pathological myopia with degeneration that affects diagnostic imaging
  • Clinically significant ocular pathology or degenerative diseases that affect vision, visual field, or optical coherence tomography of optic nerve.
  • Inability to perform reliable Visual Field and optical coherence tomography.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
58 participants (actual)

Study arms

  • Active comparator
    Combined cataract surgery with Hydrus microstent

    Device: Combined cataract surgery with Hydrus microstent · Device: Combined cataract surgery with iStent Inject W

  • Active comparator
    Combined cataract surgery with iStent Inject W

    Device: Combined cataract surgery with Hydrus microstent · Device: Combined cataract surgery with iStent Inject W

Interventions

  • DeviceCombined cataract surgery with Hydrus microstent

    Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.

  • DeviceCombined cataract surgery with iStent Inject W

    Device designed to help lower intraocular pressure by improving aqueous outflow through the trabecular meshwork. Used in combination with cataract surgery.

06

What researchers measure

Primary outcomes

  1. Percentage of subjects with complete success defined as intraocular pressure reduction > 25% from baseline And without secondary intervention to reduce IOP (medication, laser trabeculoplasty, or surgery) at 24 month.

    Time frame: 24 Months

Secondary outcomes

  1. Intraoperative and postoperative adverse events rates

    Time frame: 24 Months

  2. Rates of secondary intervention to reduce intraocular pressure

    Time frame: 24 Months

  3. Rates of needing incisional glaucoma surgery as secondary intervention to control interocular pressure

    Time frame: 24 Months

07

Study locations

1 site
  • Diablo Eye Associates
    Walnut Creek, California 94598, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05583591
Lead sponsor
Diablo Eye Associates
Collaborators
Alcon Research
Responsible party
Sponsor
First posted
Oct 17, 2022
Start date
Oct 1, 2022
Primary completion
Apr 22, 2024
Completion
Apr 22, 2024
Last update
Nov 1, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Glaucoma→

Start the discussion