GlaucomaNCT07623434
Comparison of Safety and Efficacy of Hydrus and iStent Combined With Phacoemulsyfication in Open Angle Glaucoma Patients Long-Term Follow-Up
A study testing Hydrus combined with the phacoemulsification cataract procedure and iStent with the phacoemulsification cataract procedure in people with Glaucoma, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
Comparison of Safety and Efficacy of Hydrus and iStent combined with Phacoemulsyfication in Open Angle Glaucoma Patients a Long-Term Follow-Up Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Hydrus combined with the phacoemulsification cataract procedure and iStent with the phacoemulsification cataract procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2015to 22 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the cataract which had a significant effect on the visual acuity of the patients and one of the following conditions: progression of glaucoma in visual field confirmed by two consecutive examinations by the Humphrey visual field analyzer with SITA Standard 24-2 algorithm in the course of primary open-angle glaucoma despite the use of IOP-lowering medications (1 to 4 active ingredients) or patients not tolerating or adhering to the treatment.
Who cannot join
- lack of consent for study participation, narrow-angle or closed-angle glaucoma, secondary glaucoma (including the course of psudoexfoliation syndrome, pigmentary glaucoma), advanced glaucoma, severe proliferative diabetic retinopathy, cloudy cornea, advanced macular degeneration, history of glaucoma surgical interventions (as well as trabeculoplasty), and use of more than four IOP-lowering medications
Trial locations and contacts
1 site in 1 country.
Poland1 site
Military Institute of Medicine - National Research Institute
Warsaw, Mazovian, 04-141
About this study
Comparison of Safety and Efficacy of Hydrus and iStent combined with Phacoemulsyfication in Open Angle Glaucoma Patients a Long-Term Follow-Up
Read the detailed description
Purpose of the study is to compare the effectiveness and safety of two micro-invasive glaucoma surgery devices: Hydrus Microstent and iStent Trabecular Bypass in combination with cataract phacoemulsification in the treatment of open-angle glaucoma. We additionally analyze the impact of preoperative factors on achieving surgical success in both surgical methods.
- Conditions
- Glaucoma
- Being tested
- Hydrus combined with the phacoemulsification cataract procedure, iStent with the phacoemulsification cataract procedure
- Keywords
- Glaucoma, iStent, Hydrus, microinvasive glaucoma surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrus combined with the phacoemulsification cataract procedureDevice
Cataract phacoemulsification with implantation of an artificial posterior chamber lens insertion into the capsular bag was first performed and subsequently the implantation of the Hydrus microscent was undertaken using a direct gonioscope lens. The injector ended with a cannula with a Hydrus microimplant was introduced through the same temporal incision that was used during the cataract stage.
iStent with the phacoemulsification cataract procedureDevice
Cataract phacoemulsification with implantation of an artificial posterior chamber lens insertion into the capsular bag was first performed and subsequently the implantation of the iStent implantation a 23 gauge applicator was used. iStent was gently advanced through the tra-becular meshwork and placed in the Schelmm's Canal in the inferior nasal position (3:00 to 4:00 hours in the right eye, 8:00 to 9:00 hours in the left eye).
| Study group | Role | What they receive |
|---|---|---|
| iStent | Active comparator | 35 patients had surgical treatment with the 1st generation iStent implant combined with the phacoemulsification cataract procedure Receives: Device: iStent with the phacoemulsification cataract procedure |
| Hydrus | Active comparator | 30 patients underwent surgery with the Hydrus implant combined with the phacoemulsification cataract procedure Receives: Device: Hydrus combined with the phacoemulsification cataract procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Intraocular Pressure
Measured: 10 years
BCVA
The change of best- corrected visual acuity
Measured: 10 years
Medications
Median number of patients who took medications before surgery and up until the end of the study
Measured: 10 years
Secondary outcomes (2)
CCT
Central corneal thickness
Measured: 10 years
Visual Field
Visual Field of the mean defect
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jan 2015
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Model description
- A prospective non-randomized comparative study
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623434
- Sponsor's protocol ID
- 75/WIM/2015
- Status last verified
- Jan 2015
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Hydrus and iStent Combined With Phacoemulsyfication in Open Angle Glaucoma Patients Long-Term Follow-Up
- ClinicalTrials.gov ID
- NCT07623434
- Acronym / sponsor ID
- 75/WIM/2015
- Conditions
- Glaucoma
- Keywords
- Glaucoma, iStent, Hydrus, microinvasive glaucoma surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 3 Jun 2026 (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.
Comparison of Safety and Efficacy of Hydrus and iStent combined with Phacoemulsyfication in Open Angle Glaucoma Patients a Long-Term Follow-Up
Detailed description
Purpose of the study is to compare the effectiveness and safety of two micro-invasive glaucoma surgery devices: Hydrus Microstent and iStent Trabecular Bypass in combination with cataract phacoemulsification in the treatment of open-angle glaucoma. We additionally analyze the impact of preoperative factors on achieving surgical success in both surgical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective non-randomized comparative study
| Arm | Type | Receives |
|---|---|---|
| iStent | Active comparator | Device: iStent with the phacoemulsification cataract procedure35 patients had surgical treatment with the 1st generation iStent implant combined with the phacoemulsification cataract procedure |
| Hydrus | Active comparator | Device: Hydrus combined with the phacoemulsification cataract procedure30 patients underwent surgery with the Hydrus implant combined with the phacoemulsification cataract procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the cataract which had a significant effect on the visual acuity of the patients and one of the following conditions: progression of glaucoma in visual field confirmed by two consecutive examinations by the Humphrey visual field analyzer with SITA Standard 24-2 algorithm in the course of primary open-angle glaucoma despite the use of IOP-lowering medications (1 to 4 active ingredients) or patients not tolerating or adhering to the treatment.
Key exclusion criteria (1 listed)
- lack of consent for study participation, narrow-angle or closed-angle glaucoma, secondary glaucoma (including the course of psudoexfoliation syndrome, pigmentary glaucoma), advanced glaucoma, severe proliferative diabetic retinopathy, cloudy cornea, advanced macular degeneration, history of glaucoma surgical interventions (as well as trabeculoplasty), and use of more than four IOP-lowering medications
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 |
|---|---|---|
| Hydrus combined with the phacoemulsification cataract procedureCataract phacoemulsification with implantation of an artificial posterior chamber lens insertion into the capsular bag was first performed and subsequently the implantation of the Hydrus microscent was undertaken using a direct gonioscope lens. The injector ended with a cannula with a Hydrus microimplant was introduced through the same temporal incision that was used during the cataract stage. | Device | Hydrus |
| iStent with the phacoemulsification cataract procedureCataract phacoemulsification with implantation of an artificial posterior chamber lens insertion into the capsular bag was first performed and subsequently the implantation of the iStent implantation a 23 gauge applicator was used. iStent was gently advanced through the tra-becular meshwork and placed in the Schelmm's Canal in the inferior nasal position (3:00 to 4:00 hours in the right eye, 8:00 to 9:00 hours in the left eye). | Device | iStent |
Primary outcome
IOP
Time frame: 10 years
Intraocular Pressure
BCVA
Time frame: 10 years
The change of best- corrected visual acuity
Medications
Time frame: 10 years
Median number of patients who took medications before surgery and up until the end of the study
2 secondary outcomes
CCT
Time frame: 10 years
Visual Field
Time frame: 10 years
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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 Hydrus combined with the phacoemulsification cataract procedure and iStent with the phacoemulsification cataract procedure in people with Glaucoma, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 1 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 3 Jun 2026. 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 Poland. 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?
IOP (time frame: 10 years). 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?
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 3 Jun 2026.