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OpenTrials
Completed

NCT Number: NCT05968443

Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery

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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Key information

Conditions

Eye Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

KPJ Tawakkal KL Specialist Hospital

Kuala Lumpur, 53000, Malaysia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria have been set

Treatment and study plan

ophthalmic surgery

Device

any ophthalmic surgery using Dafilon® suture

Primary outcomes

  1. Number of Suture material complications

    Time frame: 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 outcomes

  1. Number of Intra-operative complications

    Time frame: intraoperatively

    Number of Intra-operative complications as documented in the patient's record

  2. Number of Post-operative complications

    Time frame: 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

  3. Incidence of recurrence

    Time frame: up to the retrospective examination (2 to 4 years postoperatively)

    Cumulative number of recurrencies

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study 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)

Acronym: OPHTHADA

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 1, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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