Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries

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

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Open Angle Glaucoma (POAG); Secondary Open Angle Glaucoma; Open Angle Glaucoma (OAG)
• Intervention / Treatment: Procedure: Goniotomy

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David A Crandall, MD; Phone Number: 248-661-5100; Email: dcranda1@hfhs.org
• Study Contact Backup: Name: Calvin Robbins, MD; Phone Number: 313-916-3245; Email: crobbin5@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health
      • Contact: David A Crandall, MD; Phone Number: 248-661-5100; Email: dcranda1@hfhs.org
      • Contact: Calvin Robbins, MD; Phone Number: 313-916-3260; Email: crobbin5@hfhs.org
      • Sub-Investigator: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SION; Goniotomy performed with SION	Procedure: Goniotomy; Goniotomy opens the trabecular meshwork to lower intraocular pressure.
Active Comparator: BANG; Goniotomy performed with bent needle	Procedure: Goniotomy; Goniotomy opens the trabecular meshwork to lower intraocular pressure.
Active Comparator: Tanito; Goniotomy performed with Tanito hook	Procedure: Goniotomy; Goniotomy opens the trabecular meshwork to lower intraocular pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: David A Crandall, MD, Henry Ford Health

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Filtering Surgery; Trabeculectomy
• Other Study ID Numbers: 19132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No