iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment (iSKDB)

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.

Study Overview

• Status: Recruiting
• Conditions: Open Angle Glaucoma (OAG)
• Intervention / Treatment: Device: Goniotomy with KDB blade goniotomy; Device: Two iStent inject implanation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanna Konopinska; Phone Number: +48600471666; Email: joanna.konopinska@umb.edu.pl

Study Locations

• Poland
  • Bialystok, Poland, 15-089
    • Recruiting
    • Ophthalmology Clinic Medical University of Bialystok
    • Contact: Joanna Konopińska, PhD; Phone Number: +48 600471666; Email: joannakonopinska@o2.pl
  • Polska
    • Bialystok, Polska, Poland, 15-866
      • Recruiting
      • Medical University of Bialystok
      • Contact: Joanna Konopińska; Phone Number: 600471666; Email: joannakonopinska@o2.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Procedure: KDB; Cataract surgery combined with Kahook Dual Blade goniotomy.	Device: Goniotomy with KDB blade goniotomy; Goniotomy with KDB glide will be performed at the end of Cataract Surgery through the temporal cataract incision.
Active Comparator: Procedure: iStent; Cataract surgery in combination with iStent Inject W implantation	Device: Two iStent inject implanation; The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of intraocular pressure lowering medications compared to baseline	Accountability of intraocular pressure lowering medications used by the patient	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	From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: Medical University of Bialystok

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: glaucoma; iStent inject; Kahook Dual Blade goniotomy
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Filtering Surgery; Trabeculectomy
• Other Study ID Numbers: 1779

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes