Ptosis, EyelidNCT03916107
Comparison of Different Surgical Treatments for Severe Ptosis Correction
A study testing Levator muscle and tarsus resection and Frontalis flap in people with Ptosis, Eyelid, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Main research purposes of this research is to compare the therapeutic effect and safety of the superior levator muscle shortening combined with the tarsus resection and the traditional frontal muscle flap in the correction of severe ptosis. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Ptosis, Eyelid
- What is being tested?
- Levator muscle and tarsus resection and Frontalis flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unilateral ptosis patient
- the levator muscle strength less than 4mm
- primary surgery
- older than 3 years
- ocular rectus muscle of good strength;
Who cannot join
- patients who had undergone ptosis correction surgery
- patients with neurological ptosis, senile ptosis or pseudo ptosis
- patients with abnormal ocular function
- patients with Marcus-Gunn syndromes
- patients with severe systemic disease or intolerant to general anesthesia
- patients or their parents cannot finish follow-up due to educational level or various other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Comparison of Different Surgical Treatments for Severe Ptosis Correction RCT Study
Main research purposes of this research is to compare the therapeutic effect and safety of the superior levator muscle shortening combined with the tarsus resection and the traditional frontal muscle flap in the correction of severe ptosis.
Aside of above we also tend to explore the dose-effect relationship between the amount of levator muscle shortened/ tarsus resection and postoperative ptosis correction amount.So as to develop a more critical and specific guidelines for clinical treatment of ptosis.
So during the research we will recruiting patients with severe ptosis and randomly divide them into levator muscle and tarsus group and frontal muscle flap group, and follow up those patient 6 months post operation so as to evaluate the amount of correction and the side-symptoms.
Read the detailed description
The ptosis is divided into light, medium and severe according to the difference in muscle strength of the upper levator muscle. According to the previous diagnosis and treatment criteria, for the mild and moderate ptosis, it is recommended to use the method of shortening or partial resection of the levator muscle. For severe patients, because the strength of the upper levator muscles are extremely weak, the function of the upper eye lid can only be reconstructed through the strength of the frontal muscles. So it is recommended to use the frontal muscle flap surgery for correct ptosis. However, compared with the levator levator shortening, the shortcoming of the frontal muscle suspension is to change the nature anatomical relationship of the upper eyelid, resulting in unnatural eye lid lines, obvious frontal lines, easy recurrence and other shortcomings. In the case, this therapy turns out not to be very satisfied.
Based on years of clinical experience in treating ptosis, our research team have tried to use the levator muscle shortening combined with the tarsus resection method for more than 10 years. We have successfully cured more than 1000 patients with severe ptosis and obtained good therapeutic effects. The results are summarized and the sequence is published in several international journals and is recognized by domestic and foreign counterparts. However, for the new procedure of levator muscle shortening combined with tarsus resection, there is currently no comparative study with traditional therapy, and it is impossible to objectively evaluate its efficacy. Secondly, how to improve the long-term effect of levator muscle shortening combined with tarsus resection, whether the eyelid morphology is satisfactory, and the recurrence rate has not been reported. In addition, because the tarsus plays an important role in the shape and function of the eye, including maintaining the function of the tarsus and keeping the cornea moist, etc., the effect of partial removal of the tarsus on the original tarsus function is also worthy of further investigation.
Based on the original clinical results, the project team designed a randomized controlled single-blind study to compare the efficacy and safety of the levator muscle shortening combined with the tarsal resection and the traditional frontal muscle flap in the correction of severe ptosis. At the same time, to explore the dose-effect relationship between the shortening of the levator muscle and the amount of tarsal resection and the amount of correction of the ptosis after operation, the surgical design is more precise and personalized, which provides a scientific basis for further development of clinical diagnosis and treatment guidelines.
- Conditions
- Ptosis, Eyelid
- Being tested
- Levator muscle and tarsus resection, Frontalis flap
- Keywords
- Ptosis, Frontalis flap
- 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 and tarsus resectionProcedure or surgery
Shortening the levator muscle with resection of tarsus to correct severe ptosis
Frontalis flapProcedure or surgery
Using frontal muscle flap to correct severe ptosis
| Study group | Role | What they receive |
|---|---|---|
| Levator muscle and tarsus resection | Experimental | Not described Receives: Procedure: Levator muscle and tarsus resection |
| Frontal muscle flap | Active comparator | Not described Receives: Procedure: Frontalis flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
levator muscle's strength
Measuring the muscle strength: let the patient look straight ahead, the examiner presses the eyebrow arch horizontally with the thumb, interrupting the connection between the frontal muscle and the upper eyelids, and ask patient to look down. Then ask the patient to look up as much as they can, and the scale of this movement is the levator muscle strength.
When a normal person does not use the frontal muscle, the average scale of the upper eye lids movement is 13.37±2.55mm. The muscle strength of the upper eye lids is generally divided into three levels. The good upper eye lids movement scale is 8mm, the medium is 4~7mm, and the weak one is 0~3mm.
Measured: 6 months post the treatment
width of eyes
Measure the width of eyes while doctor shall make sure patient avoid looking up or using the frontal muscle to lift eyelids.
Measured: 6 months post the treatment
MRD (margin reflex distance)
Measure the distance from the upper temporal margin to the point of reflection at the center of the cornea, while doctor shall make sure patient avoid looking up or using the frontal muscle to lift eyelids.
Measured: 6 months post the treatment
Secondary outcomes (7)
Numbers of patients not completely corrected
Patients who are below:
- overcorrection（could result in the inability to close the eye completely）
- inadequate correction;
- recurrence of ptosis; All above is based on outcome 1,2,3
Measured: 6 months post the treatment
Numbers of patients having dry eye syndrome
using OSDI test to see if patients have dry eye syndrome
Measured: 6 months post the treatment
Numbers of patients having corneal injury
corneal injury using topography to check
Measured: 6 months post the treatment
Numbers of patients having orbital insufficiency
orbital insufficiency, using new national standard visual acuity chart to test
Measured: 6 months post the treatment
Numbers of patients having conjunctival prolapse;
based on examination result using slit-lamp microscope
Measured: 6 months post the treatment
Numbers of patients having trichiasis;
based on examination result using slit-lamp microscope
Measured: 6 months post the treatment
Numbers of patients having eye infection;
based on examination result using slit-lamp microscope
Measured: 6 months post the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
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 Shanghai Jiao Tong University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jun Yang, MD, Phd, Study director, Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916107
- Sponsor's protocol ID
- 2018-81-T72
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Surgical Treatments for Severe Ptosis Correction RCT Study
- ClinicalTrials.gov ID
- NCT03916107
- Acronym / sponsor ID
- 2018-81-T72
- Conditions
- Ptosis, Eyelid
- Keywords
- Ptosis, Frontalis flap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 16 Apr 2019 (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.
Main research purposes of this research is to compare the therapeutic effect and safety of the superior levator muscle shortening combined with the tarsus resection and the traditional frontal muscle flap in the correction of severe ptosis.
Aside of above we also tend to explore the dose-effect relationship between the amount of levator muscle shortened/ tarsus resection and postoperative ptosis correction amount.So as to develop a more critical and specific guidelines for clinical treatment of ptosis.
So during the research we will recruiting patients with severe ptosis and randomly divide them into levator muscle and tarsus group and frontal muscle flap group, and follow up those patient 6 months post operation so as to evaluate the amount of correction and the side-symptoms.
Detailed description
The ptosis is divided into light, medium and severe according to the difference in muscle strength of the upper levator muscle. According to the previous diagnosis and treatment criteria, for the mild and moderate ptosis, it is recommended to use the method of shortening or partial resection of the levator muscle. For severe patients, because the strength of the upper levator muscles are extremely weak, the function of the upper eye lid can only be reconstructed through the strength of the frontal muscles. So it is recommended to use the frontal muscle flap surgery for correct ptosis. However, compared with the levator levator shortening, the shortcoming of the frontal muscle suspension is to change the nature anatomical relationship of the upper eyelid, resulting in unnatural eye lid lines, obvious frontal lines, easy recurrence and other shortcomings. In the case, this therapy turns out not to be very satisfied.
Based on years of clinical experience in treating ptosis, our research team have tried to use the levator muscle shortening combined with the tarsus resection method for more than 10 years. We have successfully cured more than 1000 patients with severe ptosis and obtained good therapeutic effects. The results are summarized and the sequence is published in several international journals and is recognized by domestic and foreign counterparts. However, for the new procedure of levator muscle shortening combined with tarsus resection, there is currently no comparative study with traditional therapy, and it is impossible to objectively evaluate its efficacy. Secondly, how to improve the long-term effect of levator muscle shortening combined with tarsus resection, whether the eyelid morphology is satisfactory, and the recurrence rate has not been reported. In addition, because the tarsus plays an important role in the shape and function of the eye, including maintaining the function of the tarsus and keeping the cornea moist, etc., the effect of partial removal of the tarsus on the original tarsus function is also worthy of further investigation.
Based on the original clinical results, the project team designed a randomized controlled single-blind study to compare the efficacy and safety of the levator muscle shortening combined with the tarsal resection and the traditional frontal muscle flap in the correction of severe ptosis. At the same time, to explore the dose-effect relationship between the shortening of the levator muscle and the amount of tarsal resection and the amount of correction of the ptosis after operation, the surgical design is more precise and personalized, which provides a scientific basis for further development of clinical diagnosis and treatment guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levator muscle and tarsus resection | Experimental | Procedure: Levator muscle and tarsus resection |
| Frontal muscle flap | Active comparator | Procedure: Frontalis flap |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- unilateral ptosis patient
- the levator muscle strength less than 4mm
- primary surgery
- older than 3 years
- ocular rectus muscle of good strength;
Key exclusion criteria (6 listed)
- patients who had undergone ptosis correction surgery
- patients with neurological ptosis, senile ptosis or pseudo ptosis
- patients with abnormal ocular function
- patients with Marcus-Gunn syndromes
- patients with severe systemic disease or intolerant to general anesthesia
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 and tarsus resectionShortening the levator muscle with resection of tarsus to correct severe ptosis | Procedure or surgery | Levator muscle and tarsus resection |
| Frontalis flapUsing frontal muscle flap to correct severe ptosis | Procedure or surgery | Frontal muscle flap |
Primary outcome
levator muscle's strength
Time frame: 6 months post the treatment
Measuring the muscle strength: let the patient look straight ahead, the examiner presses the eyebrow arch horizontally with the thumb, interrupting the connection between the frontal muscle and the upper eyelids, and ask patient to look down. Then ask the patient to look up as much as they can, and the scale of this movement is the levator muscle strength. When a normal person does not use the frontal muscle, the average scale of the upper eye lids movement is 13.37±2.55mm. The muscle strength of the upper eye lids is generally divided into three levels. The good upper eye lids movement scale is 8mm, the medium is 4~7mm, and the weak one is 0~3mm.
width of eyes
Time frame: 6 months post the treatment
Measure the width of eyes while doctor shall make sure patient avoid looking up or using the frontal muscle to lift eyelids.
MRD (margin reflex distance)
Time frame: 6 months post the treatment
Measure the distance from the upper temporal margin to the point of reflection at the center of the cornea, while doctor shall make sure patient avoid looking up or using the frontal muscle to lift eyelids.
7 secondary outcomes
Numbers of patients not completely corrected
Time frame: 6 months post the treatment
Numbers of patients having dry eye syndrome
Time frame: 6 months post the treatment
Numbers of patients having corneal injury
Time frame: 6 months post the treatment
Numbers of patients having orbital insufficiency
Time frame: 6 months post the treatment
Numbers of patients having conjunctival prolapse;
Time frame: 6 months post the treatment
Numbers of patients having trichiasis;
Time frame: 6 months post the treatment
Numbers of patients having eye infection;
Time frame: 6 months post the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- 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.
Jun Yang, MD, Phd study director
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
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 and tarsus resection and Frontalis flap in people with Ptosis, Eyelid, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. 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 China. 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?
Results are not available in the source record.
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?
levator muscle's strength (time frame: 6 months post the treatment). The study lists 3 primary outcomes in all. 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 16 Apr 2019.