Trabecular Microbypass IStent in Patients with Glaucoma

NCT06630546 | Completed FDA Device

• 1 other identifier: 202200593B0
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Complete success and qualified success

  From enrollment to the end of treatment at 18 months

Study Arms (2)

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

EXPERIMENTAL

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; Device: phacoemulsification

phacoemulsification alone group

ACTIVE COMPARATOR

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

Interventions

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

phacoemulsification DEVICE

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yu-Ting Tsao: lead

Study Sites (1)

Chang Gung Memorial Hospital Linkou Branch

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

Location

Related Publications (1)

• Tsao YT, Yeh PH, Su WW. Comparison of Phacoemulsification Alone and With Trabecular Microbypass Stent in Primary Open-Angle Glaucoma and Normal-Tension Glaucoma: An 18-Month Outcome Study. J Ophthalmol. 2024 Nov 7;2024:4034215. doi: 10.1155/2024/4034215. eCollection 2024.

  PMID: 39544960 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma

Interventions

Mutagenesis, Insertional; Phacoemulsification

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis; Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Doctor

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: May 16, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• 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

Locations

TW (1)