RecruitingNot ApplicableNCT07325552

iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment

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


Sponsor

Medical University of Bialystok

Enrollment

100 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Weeks

Inclusion Criteria4

  • 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 Criteria4

  • 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.

Interventions

DEVICEGoniotomy with KDB blade goniotomy

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

DEVICETwo iStent inject implanation

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


Locations(2)

Medical University of Bialystok

Bialystok, Polska, Poland

Ophthalmology Clinic Medical University of Bialystok

Bialystok, Poland

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NCT07325552


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