Skip to main content
OpenTrials
Completed

NCT Number: NCT06630546

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Open Angle Glaucoma (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Istent Inject W Low Tension Glaucoma Normal Tension Glaucoma (NTG) Ocular Hypertension Optic Nerve Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital Linkou Branch

Taoyuan City, No.5, Fuxing St., Guishan Dist.,, 333, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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.

phacoemulsification

Device

A standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL).

Primary outcomes

  1. Intraocular pressure (IOP) in mmHg or percentage changes

    Time frame: From enrollment to the end of treatment at 18 months

    changes in IOP after the intervention

  2. glaucoma medication changes in number

    Time frame: From enrollment to the end of treatment at 18 months

    glaucoma medication changes in number after the intervention

  3. Visual acuity changes in LogMAR scale

    Time frame: From enrollment to the end of treatment at 18 months

    Visual acuity changes in LogMAR scale after the intervention in both group

Secondary outcomes

  1. Complete success and qualified success

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yu-Ting Tsao

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.