ClinicalTrials.gg
Not yet recruitingNCT07418853Updated Jun 11, 2026

Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries

An interventional study of Goniotomy in Open Angle Glaucoma (OAG), Primary Open Angle Glaucoma (POAG) and Secondary Open Angle Glaucoma, sponsored by Henry Ford Health System. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this study is to determine of one of three different devices to perform goniotomy to treat glaucoma at the time of cataract surgery is more or less effective than the others. The primary outcomes are to compare intraocular pressure control and glaucoma medication use up to 6 months after surgery. Participants will under combined cataract surgery and goniotomy. They will have post-operative follow up visits at 1 day, 1 week, 1 month, 3 months, and 6 month

02

Conditions studied

  • Open Angle Glaucoma (OAG)
  • Primary Open Angle Glaucoma (POAG)
  • Secondary Open Angle Glaucoma

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03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 132 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Adults ≥ 18 years old

  • Diagnosed with primary or secondary open-angle glaucoma (e.g., POAG, pigmentary, pseudoexfoliative)
  • Scheduled for phacoemulsification with planned goniotomy
  • Able to provide

Exclusion Criteria:

  • Angle-closure glaucoma

    • Prior glaucoma surgery in the study eye
    • Planned stand-alone goniotomy
    • Inability to comply with follow-up schedule
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (estimated)

Study arms

  • Active comparator
    SION

    Goniotomy performed with SION

    Procedure: Goniotomy

  • Active comparator
    BANG

    Goniotomy performed with bent needle

    Procedure: Goniotomy

  • Active comparator
    Tanito

    Goniotomy performed with Tanito hook

    Procedure: Goniotomy

Interventions

  • ProcedureGoniotomy

    Goniotomy opens the trabecular meshwork to lower intraocular pressure.

06

What researchers measure

Primary outcomes

  1. Intraocular pressure

    Eye pressure as measured by Goldmann applanation tonometry in mmHg

    Time frame: up to 6 months

  2. Medications

    number of medications to control intraocular pressure

    Time frame: up to 6 months

  3. Visual Acuity

    Measure of visual at each visit on Snellen acuity chart

    Time frame: up to 6 months

07

Study locations

1 site
  • Henry Ford Health
    Detroit, Michigan 48202, United States
    • David A Crandall, MD · Contactdcranda1@hfhs.org · 248-661-5100
    • Calvin Robbins, MD · Contactcrobbin5@hfhs.org · 313-916-3260
    • Nauman Imami, MD · Sub investigator
    • Paul Baciu, MD · Sub investigator
    • Brian Florek, MD · Sub investigator
    • Uma Jasty, MD · Sub investigator
    • Melisa Nika, MD · Sub investigator
    • Salma Noorulla, MD · Sub investigator
    • Candice Yousif, MD · Sub investigator
08

References and documents

Publications

  • Rahul Hariharan Jayaram, Akash Maheshwari, Soshian Sarrafpour, Ji Liu, Christopher Teng; Trends for Glaucoma Surgeries in the United States from 2011 and 2021 - A National Study. Invest. Ophthalmol. Vis. Sci. 2024;65(7):4641.
  • Aktas Z, Dorairaj S, Sayed M, Sheybani A, Ucgul AY, Wagner I, Khodeiry M. Ab Interno Goniotomy/Goniectomy Techniques. Turk J Ophthalmol. 2025 Jun 25;55(3):159-170. doi: 10.4274/tjo.galenos.2025.29345. Epub 2025 May 29. PubMed 40439165 ↗
  • Chihara E, Chihara T. Mid-Term Surgical Outcomes of T-Hook, 360 degrees Suture Trabeculotomy, Kahook Dual Blade, and Tanito Microhook Procedures: A Comparative Study. J Clin Med. 2025 Jun 29;14(13):4610. doi: 10.3390/jcm14134610. PubMed 40648984 ↗
  • Shute T, Green W, Liu J, Sheybani A. An Alternate Technique for Goniotomy: Description of Procedure and Preliminary Results. J Ophthalmic Vis Res. 2022 Apr 29;17(2):170-175. doi: 10.18502/jovr.v17i2.10787. eCollection 2022 Apr-Jun. PubMed 35765640 ↗
  • Bukke AN, Midha N, Mahalingam K, Beri N, Angmo D, Sharma N, Pandey S, Dada T. Outcomes of bent ab interno needle goniectomy with phacoemulsification in moderate to severe primary open angle glaucoma. Indian J Ophthalmol. 2024 Sep 1;72(9):1280-1284. doi: 10.4103/IJO.IJO_1072_24. Epub 2024 Jul 11. PubMed 38990629 ↗

Individual participant data

Plan to share: No — There will be a publication based on the results of the study. We will not be sharing individual participant data outside of our institution and all collected data will be kept on a secured drive within the Henry Ford Health System.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Mar 2028, 20 months later.

Of 100 non-industry interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 20 months is below that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2026
First posted
Feb 18, 2026
StartEst.
Jul 1, 2026
Primary completionEst.
Mar 1, 2028
CompletionEst.
Mar 1, 2028
Last update
Jun 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07418853
Responsible party
David Crandall (Principal Investigator, Henry Ford Health System) — Principal investigator
First posted
Feb 18, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Jun 11, 2026

Study contacts

David A Crandall, MD
Contact
dcranda1@hfhs.org
248-661-5100
Calvin Robbins, MD
Contact
crobbin5@hfhs.org
313-916-3245
David A Crandall, MD
principal investigator · Henry Ford Health

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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