Primary Open Angle Glaucoma (POAG)NCT06630546
Trabecular Microbypass IStent in Patients with Glaucoma
A study testing first generation iStent (Glaukos, San Clemente, CA, USA) insertion and phacoemulsification in people with Primary Open Angle Glaucoma (POAG) and Istent Inject W, run by Yu-Ting Tsao at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG), Istent Inject W, Normal Tension Glaucoma (NTG)
- What is being tested?
- first generation iStent (Glaukos, San Clemente, CA, USA) insertion and phacoemulsification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 May 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients evaluated by a clinician who require cataract surgery or cataract surgery combined with iStent implantation due to concomitant glaucoma and cataracts.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital Linkou Branch
Taoyuan City, No.5, Fuxing St., Guishan Dist.,, 333
About this study
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.
- Being tested
- first generation iStent (Glaukos, San Clemente, CA, USA) insertion, phacoemulsification
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first generation iStent (Glaukos, San Clemente, CA, USA) insertionDevice
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.
phacoemulsificationDevice
A standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP) in mmHg or percentage changes
changes in IOP after the intervention
Measured: From enrollment to the end of treatment at 18 months
glaucoma medication changes in number
glaucoma medication changes in number after the intervention
Measured: 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
Measured: From enrollment to the end of treatment at 18 months
Secondary outcomes (1)
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.
Measured: From enrollment to the end of treatment at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start16 May 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Ting Tsao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu-Ting Tsao, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630546
- Sponsor's protocol ID
- 202200593B0
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 39544960
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trabecular Microbypass IStent in Patients with Glaucoma
- ClinicalTrials.gov ID
- NCT06630546
- Acronym / sponsor ID
- 202200593B0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Yu-Ting TsaoUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) | Experimental | Device: first generation iStent (Glaukos, San Clemente, CA, USA) insertion, Device: phacoemulsificationIn 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 | Device: phacoemulsificationIn 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients evaluated by a clinician who require cataract surgery or cataract surgery combined with iStent implantation due to concomitant glaucoma and cataracts.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| first generation iStent (Glaukos, San Clemente, CA, USA) insertionIn 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 combined with one trabecular micro-bypass stent implantation (phaco-iStent) |
| phacoemulsificationA standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL). | Device | phacoemulsification alone group, phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) |
Primary outcome
Intraocular pressure (IOP) in mmHg or percentage changes
Time frame: From enrollment to the end of treatment at 18 months
changes in IOP after the intervention
glaucoma medication changes in number
Time frame: From enrollment to the end of treatment at 18 months
glaucoma medication changes in number after the intervention
Visual acuity changes in LogMAR scale
Time frame: From enrollment to the end of treatment at 18 months
Visual acuity changes in LogMAR scale after the intervention in both group
1 secondary outcome
Complete success and qualified success
Time frame: From enrollment to the end of treatment at 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 39544960Tsao 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing first generation iStent (Glaukos, San Clemente, CA, USA) insertion and phacoemulsification in people with Primary Open Angle Glaucoma (POAG) and Istent Inject W, run by Yu-Ting Tsao at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (IOP) in mmHg or percentage changes (time frame: From enrollment to the end of treatment at 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06630546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.