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NCT05968443 Clinical Trial

Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery

Eye Diseases Clinical Trial

— OPHTHADA  

Official title:
Observational, Retrospective Clinical Study in Patients Undergoing Ophthalmic Surgery Using Dafilon® Suture Material (Dafilon® USP (United States Pharmacopeia) Sizes From 8/0 to 11/0)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05968443
Other study ID # AAG-O-H-1913
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 8, 2019
Est. completion date May 10, 2022

Study information
Verified date July 2023
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date May 10, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patient operated between 2018 - 2020 undergoing any ophthalmic surgery using Dafilon® suture material (Dafilon® USP (United States Pharmacopeia) sizes from 8/0 to 11/0) at the participating hospital Exclusion Criteria: - No exclusion criteria have been set

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ophthalmic surgery
any ophthalmic surgery using Dafilon® suture

Locations
Country Name City State
Malaysia KPJ Tawakkal KL Specialist Hospital Kuala Lumpur Wilayah Persekutuan Kuala Lumpur

Sponsors (2)
Lead Sponsor Collaborator
Aesculap AG B.Braun Surgical SA

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Suture material complications Suture material complications needing suture removal or reinterventions (Re-suturing due to wound dehiscence) up to the retrospective examination (2 to 4 years postoperatively)
Secondary Number of Intra-operative complications Number of Intra-operative complications as documented in the patient's record intraoperatively
Secondary Number of Post-operative complications Cumulative number of Post-operative complications including Haemorrhage, inflammation and tissue reaction, corneal lesion, retraction, granuloma, and contracture at the postoperative follow-up examination up to the retrospective examination (2 to 4 years postoperatively)
Secondary Incidence of recurrence Cumulative number of recurrencies up to the retrospective examination (2 to 4 years postoperatively)
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