Trabecular Microbypass IStent in Patients with Glaucoma

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • No.5, Fuxing St., Guishan Dist.,
    • Taoyuan City, No.5, Fuxing St., Guishan Dist.,, Taiwan, 333
      • Chang Gung Memorial Hospital Linkou Branch

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent); 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.	Device: 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 adequate patient who wish to receive iStent insertion, 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.; Device: phacoemulsification; A standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL).
Active Comparator: phacoemulsification alone group; 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).	Device: phacoemulsification; A standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete success and qualified success	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.	From enrollment to the end of treatment at 18 months

Collaborators and Investigators

• Sponsor: Yu-Ting Tsao

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 6, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Optic Nerve Diseases; Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma
• Other Study ID Numbers: 202200593B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results

IPD Sharing Access Criteria

Eligibility for Data Access:

• Data will be shared with qualified researchers who provide a clear and scientifically valid research proposal.
• Proposals that align with the objectives of the original study or are intended for research that could contribute to the scientific understanding of the field will be considered.

Request Process:

• Interested researchers can request data by sending an email that includes a description of the intended analyses and the purpose of the research.
• No formal review process is required, but requests should demonstrate a valid scientific rationale for data access.

Mechanism for Data Sharing:

- Data will be shared via email. Once the request is received and approved, the data will be sent directly to the researcher.

Time Frame for Data Access:

- Data will be made available beginning 3 months and ending 3 years after the publication of results

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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