Eye Diseases Clinical Trial
— OPHTHADAOfficial 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)
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 |
Verified date | July 2023 |
Source | Aesculap AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 DafilonĀ® suture material (DafilonĀ® USP (United States Pharmacopeia) sizes from 8/0 to 11/0) at the participating hospital Exclusion Criteria: - No exclusion criteria have been set |
Country | Name | City | State |
---|---|---|---|
Malaysia | KPJ Tawakkal KL Specialist Hospital | Kuala Lumpur | Wilayah Persekutuan Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
Aesculap AG | B.Braun Surgical SA |
Malaysia,
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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