Ptosis, EyelidNCT04291625
Evaluation of Intraoperative Lagophthalmos Formula
A study testing Levator muscle resection in people with Ptosis, Eyelid, run by Menoufia University at 1 site in Egypt.
Trial summary
This is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Ptosis, Eyelid
- What is being tested?
- Levator muscle resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 15 Feb 2020
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- simple congenital ptosis (any degree) with levator function of 4mm or more
Who cannot join
- levator function less than 4mm
- a history of previous ptosis surgery
- other accompanying congenital diseases, such as blepharophimosis, congenital fibrosis of the extraocular muscles, Marcus Gunn (jaw-winking) syndrome, double elevator palsy and congenital third nerve palsy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ophthalmology Department, Menoufia University Hospital
Shibīn al Kawm, Menoufia
About this study
Official title: Evaluation of Intraoperative Lagophthalmos Formula for Levator Resection in Congenital Ptosis on Egyptian Patients
This is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. included 20 eyelids from 17 Egyptian children with congenital ptosis with levator function of 4mm or better, they underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula
Read the detailed description
This is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. The study included 20 eyelids of 17 Egyptian children with congenital ptosis with levator function of 4mm or better, they underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula.
Preoperative MRD 1 (Margin-to-reflex distance 1) and levator function were measured, then intraoperative palpebral fissure opening was determined from formula: Intraoperative lagophthalmos=9.08 - 0.48×Preoperative MRD1 - 0.26× Levator function. Postoperative MRD 1 was measured after 1 day, 1week,1month, 3 months and 6 months .Success was defined as postoperative MRD 1 ≥ 3 mm and difference between both eyelids height ≤ 1 mm at 6 months.
- Conditions
- Ptosis, Eyelid
- Being tested
- Levator muscle resection
- Keywords
- congenital, ptosis, levator function, MRD 1
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levator muscle resectionProcedure or surgery
Surgery was performed under general anaesthesia. Two milliliters of 2% lidocaine with 1:100 000 epinephrine is injected subcutaneously. After the upper eyelid incision at the desired crease line, the orbital septum was opened and the preaponeurotic fat was identified and dissected off the levator aponeurosis. The aponeurosis was disinserted from the tarsus, and the complex of levator aponeurosis and Muller muscle was dissected free from the conjunctiva. The desired eyelid height was determined from the proposed formula.
Satisfactory Intraoperative lagophthalmos was defined as a difference of less than 1 mm between recommended by the formula and actual intraoperative lagophthalmos.
After permanent fixation, a caliper was used for precise measurement of lagophthalmos in a supine position. Additional sutures were placed on the medial and lateral sides for satisfactory eyelid contour. The redundant levator complex was excised. Eyelid crease was made by placing three interrupted sutures
| Study group | Role | What they receive |
|---|---|---|
| congenital ptosis | Other | children who had congenital ptosis with levator function of 4mm or better, underwent levator muscle resection guided by intraoperative lagophthalmos formula. Receives: Procedure: Levator muscle resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chick the validity of Lagophthalmos formula for Egyptian children with congenital ptosis
We apply the following formula:
Intraoperative lagophthalmos=9.08 - 0.48×Preoperative MRD1 - 0.26×Levator function.
We tried to achieve the calculated lagophthalmos by the formula intraoperatively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ptosis, EyelidStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Model description
- 20 eyelids with congenital ptosis with levator function of 4 mm or better, who underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh S. Mandour, Menoufia University
- Investigators
- Tarek Rakha, MBBch, Study chair, Kafr Elsheikh eye surgery center, Kafr Elsheikh, EgyptAmr Awara, MD, Study chair, Tanta University, Tanta, Gharbia, EgyptAbdel Khalek I Elsaadany, PhD, Study director, Menoufia University, Shebin El Koum, Menoufia, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291625
- Sponsor's protocol ID
- 19519OPHT38
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Lagophthalmos Formula for Levator Resection in Congenital Ptosis on Egyptian Patients
- ClinicalTrials.gov ID
- NCT04291625
- Acronym / sponsor ID
- 19519OPHT38
- Conditions
- Ptosis, Eyelid
- Keywords
- congenital, ptosis, levator function, MRD 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 2 Mar 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.
This is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. included 20 eyelids from 17 Egyptian children with congenital ptosis with levator function of 4mm or better, they underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula
Detailed description
This is a prospective non-randomized study to evaluate the recent intraoperative lagophthalmos formula method for levator resection in determining postoperative eyelid height in congenital ptosis on Egyptian children. The study included 20 eyelids of 17 Egyptian children with congenital ptosis with levator function of 4mm or better, they underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula.
Preoperative MRD 1 (Margin-to-reflex distance 1) and levator function were measured, then intraoperative palpebral fissure opening was determined from formula: Intraoperative lagophthalmos=9.08 - 0.48×Preoperative MRD1 - 0.26× Levator function. Postoperative MRD 1 was measured after 1 day, 1week,1month, 3 months and 6 months .Success was defined as postoperative MRD 1 ≥ 3 mm and difference between both eyelids height ≤ 1 mm at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 eyelids with congenital ptosis with levator function of 4 mm or better, who underwent levator muscle resection guided by the recent intraoperative lagophthalmos formula.
| Arm | Type | Receives |
|---|---|---|
| congenital ptosis | Other | Procedure: Levator muscle resectionchildren who had congenital ptosis with levator function of 4mm or better, underwent levator muscle resection guided by intraoperative lagophthalmos formula. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- simple congenital ptosis (any degree) with levator function of 4mm or more
Key exclusion criteria (3 listed)
- levator function less than 4mm
- a history of previous ptosis surgery
- other accompanying congenital diseases, such as blepharophimosis, congenital fibrosis of the extraocular muscles, Marcus Gunn (jaw-winking) syndrome, double elevator palsy and congenital third nerve palsy
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 muscle resectionSurgery was performed under general anaesthesia. Two milliliters of 2% lidocaine with 1:100 000 epinephrine is injected subcutaneously. After the upper eyelid incision at the desired crease line, the orbital septum was opened and the preaponeurotic fat was identified and dissected off the levator aponeurosis. The aponeurosis was disinserted from the tarsus, and the complex of levator aponeurosis and Muller muscle was dissected free from the conjunctiva. The desired eyelid height was determined from the proposed formula. Satisfactory Intraoperative lagophthalmos was defined as a difference of less than 1 mm between recommended by the formula and actual intraoperative lagophthalmos. After permanent fixation, a caliper was used for precise measurement of lagophthalmos in a supine position. Additional sutures were placed on the medial and lateral sides for satisfactory eyelid contour. The redundant levator complex was excised. Eyelid crease was made by placing three interrupted sutures | Procedure or surgery | congenital ptosis |
Primary outcome
Chick the validity of Lagophthalmos formula for Egyptian children with congenital ptosis
Time frame: 6 months
We apply the following formula: Intraoperative lagophthalmos=9.08 - 0.48×Preoperative MRD1 - 0.26×Levator function. We tried to achieve the calculated lagophthalmos by the formula intraoperatively
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 2 Mar 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.
Tarek Rakha, MBBch study chair
Kafr Elsheikh eye surgery center, Kafr Elsheikh, Egypt
Amr Awara, MD study chair
Tanta University, Tanta, Gharbia, Egypt
Abdel Khalek I Elsaadany, PhD study director
Menoufia University, Shebin El Koum, Menoufia, Egypt
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 muscle resection in people with Ptosis, Eyelid, run by Menoufia 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 1 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 2 Mar 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?
Chick the validity of Lagophthalmos formula for Egyptian children with congenital ptosis (time frame: 6 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 2 Mar 2020.