H40.1
Conditions
Interventions
Group 1: Trabeculectomy
Group 2: Preserflo Implantation
Sponsors
Johannes Gutenberg Universität Mainz, Augenklinik
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Primary open-angle glaucoma Insufficient tensioregulation under local therapy (at least >17 mmHg, Tmax >24 mmHg) with clinical indication for filtering surgical therapy on the study eye Legal capacity to give informed consent Sufficient knowledge of German to answer the questionnaires
Exclusion criteria
Exclusion criteria: Other forms of glaucoma such as secondary glaucoma, narrow-angle glaucoma, PEX glaucoma, uveitic glaucoma, pigment dispersion glaucoma or juvenile glaucoma in the study eye No previous filtering surgery or cyclodestructive procedures in the study eye Pregnant or breastfeeding women Previous incision surgery involving the conjunctiva or other pathologies (e.g. conjunctiva, pterygium in the target quadrant) Conjunctiva, pterygium) in the target quadrant Active neovascularization of the iris Active inflammation (e.g. blepharitis, conjunctivitis, scleritis, keratitis, uveitis) Vitreous body in the anterior chamber Presence of an intraocular lens in the anterior chamber (ACIOL) Intraocular silicone oil Presence of corneal scarring Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life (SF36 2.0) after one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity, intraocular pressure, visual field (MD), RNFL thickness, events, further surgeries, NEI-VFQ-25, GQL, OSDI questionnaires 1 and 4 weeks, 3, 6, 9 and 12 months and yearly till 5 years after surgery | — |
Countries
Germany
Contacts
Public ContactAlexander Schuster
Johannes Gutenberg Universität, Augenklinik
Outcome results
None listed