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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Goniotomy with KDB blade goniotomy

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

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.

Locations (2)

Medical University of Bialystok
Bialystok, Polska, Poland
Ophthalmology Clinic Medical University of Bialystok
Bialystok, Poland