Eye DiseasesOPHTHADANCT05968443
Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery
An observational study of Eye Diseases, run by Aesculap AG at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Diseases
- What is being tested?
- ophthalmic surgery
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteMalaysia
- Study dates
- 8 Jan 2019to 10 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients who underwent any ophthalmic surgery using Dafilon® suture in the participating centre between 2018 and 2020.
Who may be able to join
- 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
Who cannot join
- No exclusion criteria have been set
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
KPJ Tawakkal KL Specialist Hospital
Kuala Lumpur, Kuala Lumpur, 53000
About this study
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)
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.
- Conditions
- Eye Diseases
- Being tested
- ophthalmic surgery
- Keywords
- Ophthalmologic Surgery
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmic surgeryDevice
any ophthalmic surgery using Dafilon® suture
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Suture material complications
Suture material complications needing suture removal or reinterventions (Re-suturing due to wound dehiscence)
Measured: up to the retrospective examination (2 to 4 years postoperatively)
Secondary outcomes (3)
Number of Intra-operative complications
Number of Intra-operative complications as documented in the patient's record
Measured: intraoperatively
Number of Post-operative complications
Cumulative number of Post-operative complications including Haemorrhage, inflammation and tissue reaction, corneal lesion, retraction, granuloma, and contracture at the postoperative follow-up examination
Measured: up to the retrospective examination (2 to 4 years postoperatively)
Incidence of recurrence
Cumulative number of recurrencies
Measured: up to the retrospective examination (2 to 4 years postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start8 Jan 2019
- Primary completion1 Jul 2021
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Hamidah H Budin, Dr., Principal investigator, KPJ Tawakkal KL Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968443
- Sponsor's protocol ID
- AAG-O-H-1913
- Acronym
- OPHTHADA
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05968443
- Acronym / sponsor ID
- OPHTHADA / AAG-O-H-1913
- Conditions
- Eye Diseases
- Keywords
- Ophthalmologic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent any ophthalmic surgery using Dafilon® suture in the participating centre between 2018 and 2020.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria have been set
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ophthalmic surgeryany ophthalmic surgery using Dafilon® suture | Device | – |
Primary outcome
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)
3 secondary outcomes
Number of Intra-operative complications
Time frame: intraoperatively
Number of Post-operative complications
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamidah H Budin, Dr. principal investigator
KPJ Tawakkal KL Specialist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases, run by Aesculap AG at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Suture material complications (time frame: up to the retrospective examination (2 to 4 years postoperatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.