Trials / Completed
CompletedNCT06630546
Trabecular Microbypass IStent in Patients with Glaucoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Yu-Ting Tsao · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2022-05-16
- Primary completion
- 2023-04-30
- Completion
- 2023-04-30
- First posted
- 2024-10-08
- Last updated
- 2024-10-08
Locations
1 site across 1 country: Taiwan
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06630546. Inclusion in this directory is not an endorsement.