Recruiting
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.
ClinicalTrials.gov IDNCT07325552
PhaseNA
Enrollment100
SponsorMedical University of Bialystok
Age18 Weeks
SexALL
Conditions studied
Open Angle Glaucoma (OAG)
About this study
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.
Interventions
- 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.
Primary outcomes
- Change in the number of intraocular pressure lowering medications compared to baseline (From enrollment to the end of treatment at 12 months)
- Intraocular pressure measured by Goldmann applanation tonometry (GAT) (From enrollment to the end of treatment at 12 months)
Eligibility information
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.
Study locations
- Medical University of Bialystok, Bialystok, Polska 15-866 Poland
- Ophthalmology Clinic Medical University of Bialystok, Bialystok, 15-089 Poland
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.