Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery
NCT05968443 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2023-08-01
Summary
This is an observational, retrospective postmarket clinical follow-up study and includes all patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres between 2018 and 2020, therefore no sample size can be given but the planned sample size shall be at least 200 eyes (around 100 patients depending on the number of operated eyes per patient) to conduct meaningful subgroup analysis.
Conditions
- Eye Diseases
Interventions
- DEVICE
-
ophthalmic surgery
any ophthalmic surgery using Dafilon® suture
Sponsors & Collaborators
-
B.Braun Surgical SA
collaborator INDUSTRY -
Aesculap AG
lead INDUSTRY
Principal Investigators
-
Hamidah H Budin, Dr. · KPJ Tawakkal KL Specialist Hospital
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-08
- Primary Completion
- 2021-07-01
- Completion
- 2022-05-10
Countries
- Malaysia
Study Locations
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