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iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment

NCT07325552 — Not applicable, Recruiting, 100 participants, Medical University of Bialystok

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

RegistryNCT07325552, acronym iSKDB
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment100 (Estimated)
SponsorMedical University of Bialystok (Other)
ConditionsOpen Angle Glaucoma (OAG)
InterventionsGoniotomy with KDB blade goniotomy, Two iStent inject implanation (Device)
Datesstart 2026-01-01, primary completion 2027-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2026-01-08, last updated 2026-01-08
Locations2 sites in Poland

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-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.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Procedure: KDBActive comparatorDevice: Goniotomy with KDB blade goniotomyCataract surgery combined with Kahook Dual Blade goniotomy.
Procedure: iStentActive comparatorDevice: Two iStent inject implanationCataract surgery in combination with iStent Inject W implantation
  • 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.

+Outcome measures

Primary outcomes

  • 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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Weeks to any

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.

+Locations (2)

FacilityCityCountryStatus
Medical University of BialystokBialystok, PolskaPolandRecruiting
Ophthalmology Clinic Medical University of BialystokBialystokPolandRecruiting

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