H40.1
Conditions
Interventions
Group 1: Observation with the iStent implant
Visit 1 - Screening
The following data will be collected from you during this visit:
- Date of birth / Gender / Ethnic origin / Place of residence / Medic
Sponsors
Universitätsklinikum Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: We aim to include patients with mild to moderate glaucoma and age-related cataract being listed for combined glaucoma surgery (phaco plus stent). Patients with washed out (4 weeks) IOP between 21 and 33 mmHg will be included. Only patients with primary open angle glaucoma will be listed
Exclusion criteria
Exclusion criteria: • Patients with any other form of primary or secondary glaucoma than primary open angle glaucoma • Pregnant or breastfeeding persons • Patients under 18 years • Visual Field mean deviation greater than -12 dB • Patients having undergone previous glaucoma surgery (except SLT) within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of correct positioning of the stents in the trabecular meshwork and of Schlemm canal respectively as yes and no as measured with anterior segment OCT after 3 months. Detailed information of exact location and amount of dislocation will be given as well | — |
Secondary
| Measure | Time frame |
|---|---|
| • the correct positioning of the stents in the trabecular meshwork respectively as yes and no as measured with gonioscopy 1 day & 3 mths postop • % of correct positioning of stents in the TM and by AS-OCT 1 day postop • the dilatation of the Schlemm Canal in diameter in µm at stent positioning and 2 clock hours apart as measured by anterior segment OCT IOP (mmHg) change preop (screening visit) to 1 day & 3 mths postop** Explorative Endpoints will be • % of endothelial cell loss (preop to 3 months postop) • Number of Glaucoma medications (preop to 3 months postop) • BCDVA in logMAR after 3 months • Time for Stent implantation in seconds (insertion of the stent injector in the eye till proper stent position) • Surgeons grading of stent positioning from 1 (not confident at all, repositioning needed) -5 (perfect positioning)/Aggregating factors during surgery (reflux bleeding etc. ) | — |
Countries
Germany
Contacts
Public ContactVerena Prokosch
Universitätsklinikum Köln
Outcome results
None listed