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.
Study Type
OBSERVATIONAL
Enrollment
200
any ophthalmic surgery using Dafilon® suture
KPJ Tawakkal KL Specialist Hospital
Kuala Lumpur, Kuala Lumpur, Malaysia
Number of Suture material complications
Suture material complications needing suture removal or reinterventions (Re-suturing due to wound dehiscence)
Time frame: up to the retrospective examination (2 to 4 years postoperatively)
Number of Intra-operative complications
Number of Intra-operative complications as documented in the patient's record
Time frame: 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
Time frame: up to the retrospective examination (2 to 4 years postoperatively)
Incidence of recurrence
Cumulative number of recurrencies
Time frame: up to the retrospective examination (2 to 4 years postoperatively)
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