BlepharoptosisNCT04214379
Management of Severe Congenital Blepharoptosis
A study testing Ptosis surgery in people with Blepharoptosis, run by Minia University at 1 site in Egypt.
Trial summary
Frontalis sling surgery was carried out using Ptose-up under general anaesthesia for patients with severe congenital ptosis. Read more about this study
- Who is it for?
- Ages 11 months to 9 years
- Conditions the study is for
- Blepharoptosis
- What is being tested?
- Ptosis surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2017to 17 Sep 2018
- Phase
- Interventional
- 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 11 months to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Severe congenital blepharoptosis
- Poor levator muscle function
- No previous ptosis surgery
Who cannot join
- Patients with Jaw winking phenomenon
- Blepharophimosis syndrome
- Congenital myasthenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Polytetrafluoroethylene (Ptose-up) in Management of Severe Congenital Blepharoptosis
Frontalis sling surgery was carried out using Ptose-up under general anaesthesia for patients with severe congenital ptosis.
Read the detailed description
Frontalis sling surgery was carried out using Ptose-up for patients with severe congenital ptosis in 23 eyes of 15 patients and they followed up for at least 6 months to detect the success rate and if there is any postoperative complications.
- Conditions
- Blepharoptosis
- Being tested
- Ptosis surgery
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ptosis surgeryProcedure or surgery
Frontalis sling surgery using pose-up and Wright's fascia-lata needle
| Study group | Role | What they receive |
|---|---|---|
| severe congenital ptosis | Other | Patients with severe congenital ptosis with poor levator muscle function Receives: Procedure: Ptosis surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of ptosis
The average marginal reflex distance was improved from -0.8 mm preoperative to +2.73 mm after 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Feb 2017
- Primary completion10 Mar 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farag Khalil Ibrahiem, Minia University
- Investigators
- Mohamed F Ibrahiem, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214379
- Sponsor's protocol ID
- Oculoplastic Unit
- Status last verified
- Dec 2019
- First submitted
- 28 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Polytetrafluoroethylene (Ptose-up) in Management of Severe Congenital Blepharoptosis
- ClinicalTrials.gov ID
- NCT04214379
- Acronym / sponsor ID
- Oculoplastic Unit
- Conditions
- Blepharoptosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 2 Jan 2020 (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.
Frontalis sling surgery was carried out using Ptose-up under general anaesthesia for patients with severe congenital ptosis.
Detailed description
Frontalis sling surgery was carried out using Ptose-up for patients with severe congenital ptosis in 23 eyes of 15 patients and they followed up for at least 6 months to detect the success rate and if there is any postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe congenital ptosis | Other | Procedure: Ptosis surgeryPatients with severe congenital ptosis with poor levator muscle function |
Who may qualify
- Ages
- 11 months to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Severe congenital blepharoptosis
- Poor levator muscle function
- No previous ptosis surgery
Key exclusion criteria (3 listed)
- Patients with Jaw winking phenomenon
- Blepharophimosis syndrome
- Congenital myasthenia
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 |
|---|---|---|
| Ptosis surgeryFrontalis sling surgery using pose-up and Wright's fascia-lata needle | Procedure or surgery | severe congenital ptosis |
Primary outcome
Improvement of ptosis
Time frame: 3 months
The average marginal reflex distance was improved from -0.8 mm preoperative to +2.73 mm after 3 months
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 3 Jan 2020.
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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.
Mohamed F Ibrahiem, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ptosis surgery in people with Blepharoptosis, run by Minia University at 1 site in Egypt.
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 3 inclusion and 3 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 3 Jan 2020. 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 Egypt. 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?
Improvement of ptosis (time frame: 3 months). 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 3 Jan 2020.