Prospective observational study on long-term results after glaucoma surgery - substudy: endothelial cell count following Paul Glaucoma Implant surgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033596

Enrollment

Registered

2024-02-21

Start date

2024-01-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H40

Interventions

Group 1: Paul Glaucoma Implant surgery

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Written informed consent to the main study (DRKS00033556) • Clinic indication for Paul Glaucoma Implant surgery • Successful peroperative endothelial cell count

Exclusion criteria

Exclusion criteria: • Previous glaucoma drainage implantation • Present corneal decompensation • Language barrier • Withdrawal of planned surgery • Patients without ability to consent or minors • Patients with known addictions

Design outcomes

Primary

Measure	Time frame
Change of endothelial cell count (loss) in patients with Paul Glaucoma Implant surgery peroperatively to 24 months postoperatively at the central cornea	—

Secondary

Measure	Time frame
- endothelial cell count (ECC) follow-up curve over 24 months (at 3, 6, 12, and 24 months; central cornea and in all quadrants) - relationship between ECC loss and tube position between iris and corneal endothelium - course of corneal tomography using Scheimpflug imaging - frequency of impaired ocular motility following Paul Glaucoma Implant surgery - other endpoints investigated in the main study (DRKS00033556)	—

Measure

Time frame

- endothelial cell count (ECC) follow-up curve over 24 months (at 3, 6, 12, and 24 months; central cornea and in all quadrants) - relationship between ECC loss and tube position between iris and corneal endothelium - course of corneal tomography using Scheimpflug imaging - frequency of impaired ocular motility following Paul Glaucoma Implant surgery - other endpoints investigated in the main study (DRKS00033556)

—

Countries

Germany

Contacts

Public ContactEsther M. Hoffmann

Augeklinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz

ehoffman@unimedizin-mainz.de+496131170

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026