iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment

NCT ID: NCT07325552

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-01-01

Brief Summary

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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

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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

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Open Angle Glaucoma (OAG)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Procedure: KDB

Cataract surgery combined with Kahook Dual Blade goniotomy.

Group Type ACTIVE_COMPARATOR

Goniotomy with KDB blade goniotomy

Intervention Type DEVICE

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

Procedure: iStent

Cataract surgery in combination with iStent Inject W implantation

Group Type ACTIVE_COMPARATOR

Two iStent inject implanation

Intervention Type DEVICE

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

Interventions

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Goniotomy with KDB blade goniotomy

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Bialystok

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical University of Bialystok

Bialystok, Polska, Poland

Site Status RECRUITING

Ophthalmology Clinic Medical University of Bialystok

Bialystok, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Joanna Konopinska

Role: CONTACT

+48600471666

Facility Contacts

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Joanna Konopińska

Role: primary

600471666

Joanna Konopińska, PhD

Role: primary

600471666 ext. +48

Other Identifiers

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1779

Identifier Type: -

Identifier Source: org_study_id

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