OPHTHADA: Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery

Sponsor

Aesculap AG (Industry)

Overall Status

Completed

CT.gov ID

NCT05968443

Collaborator

B.Braun Surgical SA (Industry)

200

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases	Device: ophthalmic surgery

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official 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)

Actual Study Start Date :

Jan 8, 2019

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

May 10, 2022

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

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 exclusion criteria have been set

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KPJ Tawakkal KL Specialist Hospital	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur	Malaysia	53000

Sponsors and Collaborators

Aesculap AG
B.Braun Surgical SA

Investigators

Principal Investigator: Hamidah H Budin, Dr., KPJ Tawakkal KL Specialist Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aesculap AG

ClinicalTrials.gov Identifier:

NCT05968443

Other Study ID Numbers:

AAG-O-H-1913

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aesculap AG

Ophthalmologic Surgery

Additional relevant MeSH terms:

Eye Diseases

Study Results

No Results Posted as of Aug 1, 2023