Trabecular Microbypass IStent in Patients with Glaucoma

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma (POAG); Istent Inject W; Normal Tension Glaucoma (NTG)
• Interventions: Device: phacoemulsification; Device: first generation iStent (Glaukos, San Clemente, CA, USA) insertion

• Registration Number: NCT06630546
• Lead Sponsor: Yu-Ting Tsao

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-16
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-06
• Last Update Submitted: 2024-10-06
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
phacoemulsification alone group	phacoemulsification	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).
phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent)	first generation iStent (Glaukos, San Clemente, CA, USA) insertion	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.
phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent)	phacoemulsification	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.

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP) in mmHg or percentage changes	From enrollment to the end of treatment at 18 months	changes in IOP after the intervention
glaucoma medication changes in number	From enrollment to the end of treatment at 18 months	glaucoma medication changes in number after the intervention
Visual acuity changes in LogMAR scale	From enrollment to the end of treatment at 18 months	Visual acuity changes in LogMAR scale after the intervention in both group

Secondary Outcome Measures

Name	Time	Method
Complete success and qualified success	From enrollment to the end of treatment at 18 months	Complete success was defined as postsurgical IOP of less than 21 mmHg without the use of any glaucoma medication, while qualified success was defined as postsurgical IOP not exceeding 21 mmHg with a reduction of one or more antiglaucoma agents compared to baseline.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital Linkou Branch; 🇨🇳 Taoyuan City, No.5, Fuxing St., Guishan Dist.,, Taiwan