NCT07418853

Brief 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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

January 15, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

January 15, 2026

Last Update Submit

June 9, 2026

Conditions

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

Outcome Measures

Primary Outcomes (3)

  • Intraocular pressure

    Eye pressure as measured by Goldmann applanation tonometry in mmHg

    up to 6 months

  • Medications

    number of medications to control intraocular pressure

    up to 6 months

  • Visual Acuity

    Measure of visual at each visit on Snellen acuity chart

    up to 6 months

Study Arms (3)

SION

ACTIVE COMPARATOR

Goniotomy performed with SION

Procedure: Goniotomy

BANG

ACTIVE COMPARATOR

Goniotomy performed with bent needle

Procedure: Goniotomy

Tanito

ACTIVE COMPARATOR

Goniotomy performed with Tanito hook

Procedure: Goniotomy

Interventions

GoniotomyPROCEDURE

Goniotomy opens the trabecular meshwork to lower intraocular pressure.

BANGSIONTanito

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Angle-closure glaucoma
  • Prior glaucoma surgery in the study eye
  • Planned stand-alone goniotomy
  • Inability to comply with follow-up schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Related Publications (5)

  • 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.

    BACKGROUND

  • 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.

    PMID: 40439165BACKGROUND

  • 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.

    PMID: 40648984BACKGROUND

  • 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.

    PMID: 35765640BACKGROUND

  • 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.

    PMID: 38990629BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • David A Crandall, MD

    Henry Ford Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Crandall, MD

CONTACT

248-661-5100dcranda1@hfhs.org

Calvin Robbins, MD

CONTACT

313-916-3245crobbin5@hfhs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2026

First Posted

February 18, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)