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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SION | Active Comparator | Goniotomy performed with SION |
|
| BANG | Active Comparator | Goniotomy performed with bent needle |
|
| Tanito | Active Comparator | Goniotomy performed with Tanito hook |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goniotomy | Procedure | Goniotomy opens the trabecular meshwork to lower intraocular pressure. |
|
| 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 |
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Inclusion Criteria: Adults ≥ 18 years old
Exclusion Criteria:
Angle-closure glaucoma
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David A Crandall, MD | Contact | 248-661-5100 | dcranda1@hfhs.org | |
| Calvin Robbins, MD | Contact | 313-916-3245 | crobbin5@hfhs.org |
| Name | Affiliation | Role |
|---|---|---|
| David A Crandall, MD | Henry Ford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 40439165 | 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. | |
| 40648984 |
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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.
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Background |
| 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. |
| 35765640 | Background | 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. |
| 38990629 | Background | 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. |