Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery
- Conditions
- Eye Diseases
- Registration Number
- NCT05968443
- Lead Sponsor
- Aesculap AG
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- No exclusion criteria have been set
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Suture material complications up to the retrospective examination (2 to 4 years postoperatively) Suture material complications needing suture removal or reinterventions (Re-suturing due to wound dehiscence)
- Secondary Outcome Measures
Name Time Method Number of Intra-operative complications intraoperatively Number of Intra-operative complications as documented in the patient's record
Incidence of recurrence up to the retrospective examination (2 to 4 years postoperatively) Cumulative number of recurrencies
Number of Post-operative complications up to the retrospective examination (2 to 4 years postoperatively) Cumulative number of Post-operative complications including Haemorrhage, inflammation and tissue reaction, corneal lesion, retraction, granuloma, and contracture at the postoperative follow-up examination
Trial Locations
- Locations (1)
KPJ Tawakkal KL Specialist Hospital
🇲🇾Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia