iStent Inject Versus Goniotomy With Kahook Dual Blade in Glauocma Treatment
Recruiting · NCT07325552 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of Bialystok
View the official record on ClinicalTrials.gov →Interventions studied
Goniotomy with KDB blade goniotomyTwo iStent inject implanation
What this trial is about
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 can take part
Age range
18 Weeks and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed.
- Ophthalmology Clinic Medical University of Bialystok - Bialystok, Poland
- Medical University of Bialystok - Bialystok, Polska, Poland