Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries

NCT07418853 — Not applicable, Not yet recruiting, 132 participants, Henry Ford Health System

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Registry	NCT07418853
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	132 (Estimated)
Sponsor	Henry Ford Health System (Other)
Conditions	Open Angle Glaucoma (OAG), Primary Open Angle Glaucoma (POAG), Secondary Open Angle Glaucoma
Interventions	Goniotomy (Procedure)
Dates	start 2026-07-01 (estimated), primary completion 2028-03-01 (estimated), completion 2028-03-01 (estimated), first posted 2026-02-18, last updated 2026-06-11
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
SION	Active comparator	Procedure: Goniotomy	Goniotomy performed with SION
BANG	Active comparator	Procedure: Goniotomy	Goniotomy performed with bent needle
Tanito	Active comparator	Procedure: Goniotomy	Goniotomy performed with Tanito hook

Goniotomy (Procedure): Goniotomy opens the trabecular meshwork to lower intraocular pressure.

+Outcome measures

Primary outcomes

Intraocular pressure [up to 6 months]: Eye pressure as measured by Goldmann applanation tonometry in mmHg
Medications [up to 6 months]: number of medications to control intraocular pressure
Visual Acuity [up to 6 months]: Measure of visual at each visit on Snellen acuity chart

+Eligibility

Sex: All, ages: 18 Years to any

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 informed consent

Exclusion Criteria:

* Angle-closure glaucoma

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

+Locations (1)

Facility	City	Country	Status
Henry Ford Health	Detroit, Michigan	United States

+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. PMID 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. PMID 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. PMID 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. PMID 38990629

+Investigators

David A Crandall, MD, Principal investigator, Henry Ford Health