Open Angle Glaucoma (OAG)iSKDBNCT07325552
iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment
A study testing Goniotomy with KDB blade goniotomy and Two iStent inject implanation in people with Open Angle Glaucoma (OAG), run by Medical University of Bialystok at 2 sites in Poland.
Trial summary
The purpose of the study is to investigate the efficacy of cataract surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 weeks and older
- Conditions the study is for
- Open Angle Glaucoma (OAG)
- What is being tested?
- Goniotomy with KDB blade goniotomy and Two iStent inject implanation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only one eye per participant
- Clinically significant cataract
- Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.
- Open chamber angle with Schaffer grading three to four in at least two quadrants
Who cannot join
- Previous glaucoma surgery, including cyclodestructive procedures.
- Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.
- Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.
- Unable to participate and make written consent due to another medical condition.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Medical University of Bialystok
Bialystok, Polska, 15-866
Joanna Konopińska, 600471666, joannakonopinska@o2.pl
- Recruiting
Ophthalmology Clinic Medical University of Bialystok
Bialystok, 15-089
Joanna Konopińska, PhD, 600471666 ext. +48, joannakonopinska@o2.pl
About this study
Official title: iStent Inject Versus Goniotomy With Kahook Dual Blade in Patients With Ocular Hypertension and Glaucoma
The purpose of the study is to investigate the efficacy of cataract surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.
Read the detailed description
Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery combined with Kahook Dual Blade Glide (50 patients) or iStent Inject W (50 patients).
- Conditions
- Open Angle Glaucoma (OAG)
- Being tested
- Goniotomy with KDB blade goniotomy, Two iStent inject implanation
- Keywords
- glaucoma, iStent inject, Kahook Dual Blade goniotomy
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goniotomy with KDB blade goniotomyDevice
Goniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision.
Two iStent inject implanationDevice
The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.
| Study group | Role | What they receive |
|---|---|---|
| Procedure: KDB | Active comparator | Cataract surgery combined with Kahook Dual Blade goniotomy. Receives: Device: Goniotomy with KDB blade goniotomy |
| Procedure: iStent | Active comparator | Cataract surgery in combination with iStent Inject W implantation Receives: Device: Two iStent inject implanation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of intraocular pressure lowering medications compared to baseline
Accountability of intraocular pressure lowering medications used by the patient
Measured: From enrollment to the end of treatment at 12 months
Intraocular pressure measured by Goldmann applanation tonometry (GAT)
Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (1)
Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg
Intraocular pressure measured by Goldmann applanation tonometry (GAT) at 12 months
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma (OAG)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325552
- Sponsor's protocol ID
- 1779
- Acronym
- iSKDB
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iStent Inject Versus Goniotomy With Kahook Dual Blade in Patients With Ocular Hypertension and Glaucoma
- ClinicalTrials.gov ID
- NCT07325552
- Acronym / sponsor ID
- iSKDB / 1779
- Conditions
- Open Angle Glaucoma (OAG)
- Keywords
- glaucoma, iStent inject, Kahook Dual Blade goniotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 8 Jan 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.
The purpose of the study is to investigate the efficacy of cataract surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.
Detailed description
Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery combined with Kahook Dual Blade Glide (50 patients) or iStent Inject W (50 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedure: KDB | Active comparator | Device: Goniotomy with KDB blade goniotomyCataract surgery combined with Kahook Dual Blade goniotomy. |
| Procedure: iStent | Active comparator | Device: Two iStent inject implanationCataract surgery in combination with iStent Inject W implantation |
Who may qualify
- Ages
- 18 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Only one eye per participant
- Clinically significant cataract
- Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.
- Open chamber angle with Schaffer grading three to four in at least two quadrants
Key exclusion criteria (4 listed)
- Previous glaucoma surgery, including cyclodestructive procedures.
- Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.
- Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.
- Unable to participate and make written consent due to another medical condition.
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 |
|---|---|---|
| Goniotomy with KDB blade goniotomyGoniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision. | Device | Procedure: KDB |
| Two iStent inject implanationThe two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision. | Device | Procedure: iStent |
Primary outcome
Change in the number of intraocular pressure lowering medications compared to baseline
Time frame: From enrollment to the end of treatment at 12 months
Accountability of intraocular pressure lowering medications used by the patient
Intraocular pressure measured by Goldmann applanation tonometry (GAT)
Time frame: From enrollment to the end of treatment at 12 months
Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline
1 secondary outcome
Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Related trials for Open Angle Glaucoma (OAG)
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Recruiting
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Open Angle Glaucoma (OAG)
RecruitingObservational study
iDose TR Administration in an Office-Based Surgery Setting
Open Angle Glaucoma (OAG), Ocular Hypertension (OHT)
RecruitingPhase 1/2
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Active, not recruitingPhase 2
Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation
Non-proliferative Diabetic Retinopathy (NPDR), Open-angle Glaucoma (OAG)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goniotomy with KDB blade goniotomy and Two iStent inject implanation in people with Open Angle Glaucoma (OAG), run by Medical University of Bialystok at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna Konopinska (+48600471666, joanna.konopinska@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of intraocular pressure lowering medications compared to baseline (time frame: From enrollment to the end of treatment at 12 months). The study lists 2 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 8 Jan 2026.