Comparison of Different Surgical Treatments for Severe Ptosis Correction

April 12, 2019 updated by: Qing-FengLi Li,MD, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 78 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levator muscle and tarsus resection
Procedure: Levator muscle and tarsus resection
Shortening the levator muscle with resection of tarsus to correct severe ptosis
Active Comparator: Frontal muscle flap
Procedure: Frontalis flap
Using frontal muscle flap to correct severe ptosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post the treatment
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.
6 months post the treatment
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.
6 months post the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of patients not completely corrected
Time Frame: 6 months post the treatment

Patients who are below:

  1. overcorrection（could result in the inability to close the eye completely）
  2. inadequate correction;
  3. recurrence of ptosis; All above is based on outcome 1,2,3
6 months post the treatment
Numbers of patients having dry eye syndrome
Time Frame: 6 months post the treatment
using OSDI test to see if patients have dry eye syndrome
6 months post the treatment
Numbers of patients having corneal injury
Time Frame: 6 months post the treatment
corneal injury using topography to check
6 months post the treatment
Numbers of patients having orbital insufficiency
Time Frame: 6 months post the treatment
orbital insufficiency, using new national standard visual acuity chart to test
6 months post the treatment
Numbers of patients having conjunctival prolapse;
Time Frame: 6 months post the treatment
based on examination result using slit-lamp microscope
6 months post the treatment
Numbers of patients having trichiasis;
Time Frame: 6 months post the treatment
based on examination result using slit-lamp microscope
6 months post the treatment
Numbers of patients having eye infection;
Time Frame: 6 months post the treatment
based on examination result using slit-lamp microscope
6 months post the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Jun Yang, MD, Phd, Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-81-T72

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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