Comparison of Different Surgical Treatments for Severe Ptosis Correction

Ptosis, Eyelid Clinical Trial

Official title:

Comparison of Different Surgical Treatments for Severe Ptosis Correction RCT Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03916107
• Other study ID #: 2018-81-T72
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2019
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

Inclusion Criteria:

• unilateral ptosis patient

• the levator muscle strength less than 4mm

• primary surgery

• older than 3 years

• ocular rectus muscle of good strength;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Blepharoptosis
• Prolapse
• Ptosis, Eyelid

Intervention

Procedure:
• Levator muscle and tarsus resection
Shortening the levator muscle with resection of tarsus to correct severe ptosis
• Frontalis flap
Using frontal muscle flap to correct severe ptosis

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months post the treatment
Primary	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.	6 months post the treatment
Primary	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.	6 months post the treatment
Secondary	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	6 months post the treatment
Secondary	Numbers of patients having dry eye syndrome	using OSDI test to see if patients have dry eye syndrome	6 months post the treatment
Secondary	Numbers of patients having corneal injury	corneal injury using topography to check	6 months post the treatment
Secondary	Numbers of patients having orbital insufficiency	orbital insufficiency, using new national standard visual acuity chart to test	6 months post the treatment
Secondary	Numbers of patients having conjunctival prolapse;	based on examination result using slit-lamp microscope	6 months post the treatment
Secondary	Numbers of patients having trichiasis;	based on examination result using slit-lamp microscope	6 months post the treatment
Secondary	Numbers of patients having eye infection;	based on examination result using slit-lamp microscope	6 months post the treatment