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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ophthalmic surgery | Device | any ophthalmic surgery using Dafilon® suture |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Intra-operative complications | Number of Intra-operative complications as documented in the patient's record | intraoperatively |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who underwent any ophthalmic surgery using Dafilon® suture in the participating centre between 2018 and 2020.
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| Name | Affiliation | Role |
|---|---|---|
| Hamidah H Budin, Dr. | KPJ Tawakkal KL Specialist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KPJ Tawakkal KL Specialist Hospital | Kuala Lumpur | Kuala Lumpur | 53000 | Malaysia |
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| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| up to the retrospective examination (2 to 4 years postoperatively) |
| Incidence of recurrence | Cumulative number of recurrencies | up to the retrospective examination (2 to 4 years postoperatively) |