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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 18 months |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital Linkou Branch | Taoyuan City | No.5, Fuxing St., Guishan Dist., | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39544960 | Derived | 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. |
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all IPD that underlie results in a publication
Beginning 3 months and ending 3 years after the publication of results
Eligibility for Data Access:
Request Process:
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
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D057066 | Low Tension Glaucoma |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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|
| phacoemulsification | Device | A standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL). |
|
| D009154 |
| Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D059708 | Ultrasonic Surgical Procedures |