Trabecular Microbypass IStent in Patients with Glaucoma

Yu-Ting Tsao

Status: Completed

Conditions: Normal Tension Glaucoma (NTG); Istent Inject W; Primary Open Angle Glaucoma (POAG)

Treatments: Device: first generation iStent (Glaukos, San Clemente, CA, USA) insertion; Device: phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT06630546

202200593B0

Details and patient eligibility

About

The goal of this clinical trial is to assess the safety and efficacy of phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone in a Taiwanese population, as well as to investigate any differences in outcomes between patients with primary open angle glaucoma (POAG) and those with normal tension glaucoma (NTG). The main question it aims to answer is:

• How much do intraocular pressure (IOP) and the number of antiglaucoma medications change after iStent insertion, with subgroup analyses for POAG and NTG? Researchers will compare phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone to see if IOP and the number of antiglaucoma medications decrease.

Participants will receive their regular phacoemulsification and decided whether to receive iStent by themselves.

Enrollment: 71 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients evaluated by a clinician who require cataract surgery or cataract surgery combined with iStent implantation due to concomitant glaucoma and cataracts.

Exclusion criteria

• Eyes that have previously undergone vitrectomy or retinal surgery.
• Patients with ocular surface inflammation (e.g., corneal ulcers, orbital cellulitis, etc.).
• Patients with hypotony (intraocular pressure <5 mmHg).
• Patients with a history of globe rupture.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent)

Experimental group

Description:

In glaucoma patient who needed to receive cataract surgery, a standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL). Then, in this group, we further inserted a preloaded micro-bypass stent (model GTS100L) through the temporal corneal incision into the nasal Schlemm's canal and checked the position. Adequate intraocular pressure (IOP) was assessed by palpation at the end of the surgery.

Treatment:

Device: phacoemulsification

Device: first generation iStent (Glaukos, San Clemente, CA, USA) insertion

phacoemulsification alone group

Active Comparator group

Description:

In glaucoma patient who needed to receive cataract surgery, a standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL).

Treatment:

Device: phacoemulsification