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NCT Number: NCT07325552

iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment

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.

Recruiting

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Key information

Conditions

Open Angle Glaucoma (OAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Bialystok, Bialystok, Polska, Poland

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Goniotomy with KDB blade goniotomy

Device

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

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.

Primary outcomes

  1. Change in the number of intraocular pressure lowering medications compared to baseline

    Time frame: From enrollment to the end of treatment at 12 months

    Accountability of intraocular pressure lowering medications used by the patient

  2. Intraocular pressure measured by Goldmann applanation tonometry (GAT)

    Time frame: 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

Secondary outcomes

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

    Time frame: From enrollment to the end of treatment at 12 months

    Intraocular pressure measured by Goldmann applanation tonometry (GAT) at 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Joanna Konopinska

CONTACT

[email protected]

+48600471666

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

iStent Inject Versus Goniotomy With Kahook Dual Blade in Patients With Ocular Hypertension and Glaucoma

Acronym: iSKDB

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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