Cataract surgery with iStent inject versus Kahook Dual Blade goniotomy for open-angle glaucoma
Official title: iStent Inject Versus Goniotomy With Kahook Dual Blade in Patients With Ocular Hypertension and Glaucoma
Run by Medical University of Bialystok · NCT07325552 · Data updated 2026-11-12
This trial tests whether adding either two iStent inject implants or a Kahook Dual Blade goniotomy at the time of cataract surgery helps people with open-angle glaucoma lower eye pressure or reduce glaucoma medications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Weeks and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Medical University of Bialystok Academic / other |
| Locations | 2 sites (Bialystok, Polska and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2028 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT07325552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with open-angle glaucoma or ocular hypertension who have a clinically significant cataract, open anterior chamber angles (Schaffer grade 3–4 in at least two quadrants), use one to four glaucoma medications, and do not currently require filtering glaucoma surgery are ideal candidates.
✕Probably not a fit
Patients who have had prior glaucoma surgery, need filtering surgery, have narrow/closed angles, recent SLT, or other eye diseases that affect IOP or visual fields are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with open-angle glaucoma and a clinically significant cataract will be enrolled after providing written informed consent and meeting eligibility criteria. Eligible participants (one eye per person) will be randomized 1:1 to receive cataract surgery combined with Kahook Dual Blade Glide goniotomy (n=50) or cataract surgery combined with two iStent inject implants (n=50). The trial will compare postoperative outcomes such as intraocular pressure control and need for glaucoma medications between the two groups over scheduled follow-up visits. Key exclusion criteria include prior glaucoma surgery, recent selective laser trabeculoplasty, and other ocular diseases that affect intraocular pressure or visual field.
Why it matters
Potential benefit: If successful, the chosen procedure could lower eye pressure and reduce the number of glaucoma medications needed after cataract surgery.
How similar studies have gone: Both iStent implants and KDB goniotomy have demonstrated intraocular pressure and medication-reducing effects in prior studies, so this trial compares two established minimally invasive approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where it's running
-
Medical University of Bialystok
Bialystok, Polska, Poland Recruiting -
Ophthalmology Clinic Medical University of Bialystok
Bialystok, Poland Recruiting
Study contacts
- Study coordinator: Joanna Konopinska
- Email: joanna.konopinska@umb.edu.pl
- Phone: +48600471666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.