Prospective, controlled, randomized, monocentric clinical investigation of performance and safety of Pro-ophta® Ocular Sticks in comparison with an alternative device

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025690

Enrollment

108

Registered

2021-11-16

Start date

2022-02-11

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

H00-H59

Interventions

Group 1: Pro-ophta® Ocular Sticks Group 2: BVI Visitec® Absorbent Stick

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age = 18 years Patient is legally capable Ophthalmology surgery is performed for a patient Patient has signed a written Informed Consent

Exclusion criteria

Exclusion criteria: Known intolerability to the product Participation in other clinical study within 30 days for the study entry and during the study Patient not covered by health insurance/social security

Design outcomes

Primary

Measure	Time frame
Performance of the product, measured by level of satisfaction of the surgeon	—

Secondary

Measure	Time frame
Frequency and severity of device-related adverse events and incidents	—

Countries

Germany

Contacts

Public ContactStefanie;Martin König;Abel

Augentagesklinik am Spreebogen;Lohmann & Rauscher GmbH & Co. KG

stefanie.koenig@atk-spreebogen.de;Martin.Abel@de.LRmed.com10117;+49 (0) 2631 99 6566

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026