Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05968443

Acronym

OPHTHADA

Enrollment

200

Registered

2023-08-01

Start date

2019-01-08

Completion date

2022-05-10

Last updated

2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases

Keywords

Ophthalmologic Surgery

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.

Interventions

DEVICEophthalmic surgery

any ophthalmic surgery using Dafilon® suture

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Number of Intra-operative complications	intraoperatively	Number of Intra-operative complications as documented in the patient's record
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
Incidence of recurrence	up to the retrospective examination (2 to 4 years postoperatively)	Cumulative number of recurrencies

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026