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Patient Reported Outcome Measures in Glaucoma Surgery

Patient Reported Outcome Measures in Glaucoma Surgery - PROMIGS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038778
Enrollment
200
Registered
2025-12-22
Start date
2026-05-04
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

H40

Interventions

Group 1: The study prospectively examines the impact of glaucoma surgical procedures on patients' health-related quality of life and subjective symptoms using validated Patient Reported Outcome Measur

Sponsors

Charité - Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who are scheduled for a glaucoma surgical procedure (Istent Inject®, trabeculotomy using Trabectome or Kahook dual blade, 360° trabeculotomy following canaloplasty, ab interno canaloplasty, XEN implantation, trabeculectomy, and Ahmed valve or Paul implant), who are capable of giving consent and, after being informed, are willing to participate in the study.

Exclusion criteria

Exclusion criteria: - Persons under 18 years of age. - Persons who are mentally unable to complete the questionnaires for collecting the PROMs.

Design outcomes

Primary

MeasureTime frame
Change in the total score of the GAL-9 (Glaucoma Activity Limitation-9) questionnaire between month 12 and the preoperative measurement time point.

Secondary

MeasureTime frame
• PROMIS 29+4 • GSS (Glaucoma Symptom Scale) • NEI-VFQ-25 (National Eye Institute Visual Functioning Questionnaire) • SFQ (Surgical Fear Questionnaire) • SSQ-8 (Surgical Satisfaction Questionnaire) • Availability of data (yes/no) • Digital participation (yes/no) Demographic and clinical data: • Age and gender • Ethnic background • Severity of glaucoma • Surgeries performed • Information about the condition • Ophthalmological findings (e.g., intraocular pressure) and medications

Countries

Germany

Contacts

Public ContactAnna-Karina Maier-Wenzel

Charité - Universitätsmedizin Berlin

anna-karina.maier@charite.de+4930450654419

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026