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Clinical Trials in Poland / NCT07325552
Recruiting Not applicable

iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment

NCT07325552 · tracked via the Priya Life Science Poland tracker
Sponsor
Medical University of Bialystok
Phase
Not applicable
Started
2026-01-01
Last updated
2026-01-08

Condition(s) studied

Open Angle Glaucoma (OAG)

Investigational drug(s) / intervention(s)

Goniotomy with KDB blade goniotomyTwo iStent inject implanation

Goniotomy with KDB blade goniotomy: Goniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision.

Two iStent inject implanation: The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.

Study 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.

Eligibility

Sex
ALL
Min age
18 Weeks
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in the number of intraocular pressure lowering medications compared to baseline — 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) — 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

Trial sites (2)

FacilityCityRegionStatus
Medical University of Bialystok Bialystok Polska Recruiting
Ophthalmology Clinic Medical University of Bialystok Bialystok Poland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07325552 on ClinicalTrials.gov ↗ ← All trials in Poland