iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment

NCT07325552 | Recruiting FDA Device

• 1 other identifier: 1779
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Open Angle Glaucoma (OAG)

Keywords

glaucoma; iStent inject; Kahook Dual Blade goniotomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Procedure: KDB

ACTIVE COMPARATOR

Cataract surgery combined with Kahook Dual Blade goniotomy.

Device: Goniotomy with KDB blade goniotomy

Procedure: iStent

ACTIVE COMPARATOR

Cataract surgery in combination with iStent Inject W implantation

Device: Two iStent inject implanation

Interventions

Goniotomy with KDB blade goniotomy DEVICE

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

Procedure: KDB

Two iStent inject implanation DEVICE

The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.

Procedure: iStent

Eligibility Criteria

• Age: 18 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (2)

Medical University of Bialystok

Bialystok, Polska, 15-866, Poland

RECRUITING

Ophthalmology Clinic Medical University of Bialystok

Bialystok, 15-089, Poland

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Joanna Konopinska

CONTACT

+48600471666; joanna.konopinska@umb.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

PL (2)