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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
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.
A standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL).
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, No.5, Fuxing St., Guishan Dist.,, Taiwan
Intraocular pressure (IOP) in mmHg or percentage changes
changes in IOP after the intervention
Time frame: From enrollment to the end of treatment at 18 months
glaucoma medication changes in number
glaucoma medication changes in number after the intervention
Time frame: 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
Time frame: From enrollment to the end of treatment at 18 months
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.
Time frame: From enrollment to the end of treatment at 18 months
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