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A Randomized, Open Label, Parallel Group Comparative Study of the Efficacy and Safety of the Cataract surgery with Hydrus and the Cataract surgery with Tanito Microhook in Patients with Glaucoma and Cataracts.

Study for ab interno trabeculotomy

Sakata Rei

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku,Tokyo

reisakata@gmail.com

Sakata Rei

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku,Tokyo

+81-3-3815-5411

reisakata@gmail.com

Recruiting

Mar. 14, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1) Individuals diagnosed with cataracts
(2) Individuals undergoing phacoemulsification and intraocular lens (IOL) implantation
(3) Individuals scheduled for the insertion of a monofocal IOL into the lens capsule
(4) Individuals with early to moderate primary open-angle glaucoma (with a mean deviation (MD) value of -12dB or higher)
(5) Individuals with intraocular pressure between 10mmHg and less than 25mmHg, while using at least one type of glaucoma eye drop
(6) Individuals with a clear cornea
(7) Age: Individuals between 40 and 89 years old at the time of consent
(8) Gender: Not specified
(9) Individuals who, after receiving a sufficient explanation about participating in this study and fully understanding it, provide written informed consent of their own free will
(10) Individuals able to attend follow-up outpatient visits according to the study schedule

(1) Individuals with exfoliation glaucoma, angle-closure glaucoma, or secondary glaucoma in the subjected eye.
(2) Individuals with narrow angles classified as Shaffer grade I or II in the subjected eye.
(3) Individuals with a corneal endothelial cell density of less than 1500 cells/mm2 in the subjected eye.
(4) Individuals with congenital angle abnormalities, peripheral anterior synechiae (PAS), neovascularization, or other angle abnormalities that pose a risk of improper microstent insertion in the subjected eye.
(5) Individuals with a history of allergy to nitinol (Nickel titanium)
(6) Individuals with a history of corneal surgery that could affect intraocular pressure measurements in the subjected eye.
(7) Patients with a history of glaucoma surgery or laser treatment (such as SLT or TSCPC) in the subjected eye
(8) Individuals with other active eye diseases besides glaucoma in the subjected eye.
(9) Individuals with an axial length of 30mm or more in the subjected eye.
(10) Individuals using only dorzolamide hydrochloride/timolol maleate combination eye drops in the subjected eye.
(11) Individuals with a history of allergy to dorzolamide hydrochloride/timolol maleate combination eye drops
(12) Any other individual deemed inappropriate for participation in this study by the principal or co-investigators

Both

Cataract patients with glaucoma

At the time of combined glaucoma and cataract surgery, patients will be randomly assigned 1:1 to the group using the Hydrus Microstent device or the Tanito ab interno Trabeculotomy Micro-hook device.

glaucoma

Hydrus Microstent

Success rate of intraocular pressure (IOP) control at 6 months postoperatively.

Success rate of intraocular pressure (IOP) control at 12 months postoperatively.

+81-3-5841-0818

Feb. 20, 2025

No

None