Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery (OPHTHADA)

July 27, 2023 updated by: Aesculap AG

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 53000
        • KPJ Tawakkal KL Specialist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent any ophthalmic surgery using Dafilon® suture in the participating centre between 2018 and 2020.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to the retrospective examination (2 to 4 years postoperatively)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

B.Braun Surgical SA

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2019

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

May 10, 2022

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1913

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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