Congenital PtosisNCT03240107
Levator Resection with3 Point Fixation Versus 2 Point Fixation Tucking for Congenital Ptosis
A study testing levator resection and levator tucking in people with Congenital Ptosis, run by Heba Hamdy Ibrahim Mohammed at 1 site in Egypt.
Trial summary
to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Ptosis
- What is being tested?
- levator resection and levator tucking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Jul 2017
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Unilateral or bilateral simple isolated congenital ptosis.
- Levator function more than 4mm
Who cannot join
- Congenital ptosis associated with other ocular syndromes.
- Recurrent ptosis following any attempt for repair.
- Traumatic ptosis or acquired ptosis
- -ve bell's phenomenon.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard Levator Aponeurosis / Muscle Resection With Three Point Fixation Versus Two Point Fixation Tucking for Congenital Ptosis With Fair to Good Levator Function
to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis
Read the detailed description
Target population for the study is children under twelve years old presenting to ophthalmology clinic at Cairo university specialized pediatric hospital with congenital ptosis.
Patients will be randomly divided into two groups First group (A) will contain 20 patients who will undergo standard levator aponeurosis resection Second group (B) will contain 20 patient who will undergo two point fixation levator tucking
- Conditions
- Congenital Ptosis
- Being tested
- levator resection, levator tucking
- Keywords
- levator resection, levator tucking, Fair levator function, Eyelid contour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levator resectionProcedure or surgery
The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.
The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect.
The skin incision closed by continuous suture with 6-0 prolene.
levator tuckingProcedure or surgery
The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.
. The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene.
| Study group | Role | What they receive |
|---|---|---|
| levator resection | Active comparator | 20 patients who will undergo levator aponeurosis resection technique Receives: Procedure: levator resection |
| levator tucking | Active comparator | 20 patients who will undergo two point fixation levator tucking technique Receives: Procedure: levator tucking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1
MRD1:distance between upper lid margin and corneal light reflex measured in mm by transparent ruler
Measured: 6 to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study startMay 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital PtosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heba Hamdy Ibrahim Mohammed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heba Hamdy Ibrahim Mohammed, Cairo University
- Investigators
- RANIA AS EL ASSAWY, PhD, Study chair, Cairo UniversitySameh HA ABDEL BAKY, MD, Study director, Cairo UniversityDINA HO HASSANIEN, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240107
- Sponsor's protocol ID
- hhim123
- Status last verified
- Jul 2017
- First submitted
- 16 Dec 2016
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Levator Aponeurosis / Muscle Resection With Three Point Fixation Versus Two Point Fixation Tucking for Congenital Ptosis With Fair to Good Levator Function
- ClinicalTrials.gov ID
- NCT03240107
- Acronym / sponsor ID
- hhim123
- Conditions
- Congenital Ptosis
- Keywords
- levator resection, levator tucking, Fair levator function, Eyelid contour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Heba Hamdy Ibrahim MohammedUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Aug 2017 (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.
to evaluate the surgical effect of levator aponeurosis resection Versus two point fixation levator aponeurosis Tucking for Congenital Ptosis
Detailed description
Target population for the study is children under twelve years old presenting to ophthalmology clinic at Cairo university specialized pediatric hospital with congenital ptosis.
Patients will be randomly divided into two groups First group (A) will contain 20 patients who will undergo standard levator aponeurosis resection Second group (B) will contain 20 patient who will undergo two point fixation levator tucking
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levator resection | Active comparator | Procedure: levator resection20 patients who will undergo levator aponeurosis resection technique |
| levator tucking | Active comparator | Procedure: levator tucking20 patients who will undergo two point fixation levator tucking technique |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Unilateral or bilateral simple isolated congenital ptosis.
- Levator function more than 4mm
Key exclusion criteria (4 listed)
- Congenital ptosis associated with other ocular syndromes.
- Recurrent ptosis following any attempt for repair.
- Traumatic ptosis or acquired ptosis
- -ve bell's phenomenon.
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 |
|---|---|---|
| levator resectionThe levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva. The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect. The skin incision closed by continuous suture with 6-0 prolene. | Procedure or surgery | levator resection |
| levator tuckingThe levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva. . The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene. | Procedure or surgery | levator tucking |
Primary outcome
Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1
Time frame: 6 to 9 months
MRD1:distance between upper lid margin and corneal light reflex measured in mm by transparent ruler
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 4 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
RANIA AS EL ASSAWY, PhD study chair
Cairo University
Sameh HA ABDEL BAKY, MD study director
Cairo University
DINA HO HASSANIEN, MD study director
Cairo 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 levator resection and levator tucking in people with Congenital Ptosis, run by Heba Hamdy Ibrahim Mohammed 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 2 inclusion and 4 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 4 Aug 2017. 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?
Comparison of surgical efficacy of standard levator aponeurosis resection and two point fixation tucking regarding MRD1 (time frame: 6 to 9 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 4 Aug 2017.