NCT05968443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

July 17, 2023

Last Update Submit

July 27, 2023

Conditions

Eye Diseases

Keywords

Ophthalmologic Surgery

Outcome Measures

Primary Outcomes (1)

  • Number of Suture material complications

    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 Outcomes (3)

  • Number of Intra-operative complications

    intraoperatively

  • Number of Post-operative complications

    up to the retrospective examination (2 to 4 years postoperatively)

  • Incidence of recurrence

    up to the retrospective examination (2 to 4 years postoperatively)

Interventions

ophthalmic surgeryDEVICE

any ophthalmic surgery using Dafilon® suture

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KPJ Tawakkal KL Specialist Hospital

Kuala Lumpur, Kuala Lumpur, 53000, Malaysia

Location

MeSH Terms

Conditions

Eye Diseases

Interventions

Ophthalmologic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Hamidah H Budin, Dr.

    KPJ Tawakkal KL Specialist Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 1, 2023

Study Start

January 8, 2019

Primary Completion

July 1, 2021

Study Completion

May 10, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)