Istent Inject W, Normal Tension Glaucoma (NTG), Primary Open Angle Glaucoma (POAG)
Conditions
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.
Interventions
DEVICEfirst 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.
DEVICEphacoemulsification
A standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL).
Sponsors
Yu-Ting Tsao
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Outcome results
None listed