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Comparison of Different Surgical Treatments for Severe Ptosis Correction

Primary Purpose

Ptosis, Eyelid

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Levator muscle and tarsus resection
Frontalis flap
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ptosis, Eyelid focused on measuring Ptosis, Frontalis flap

Eligibility Criteria

3 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levator muscle and tarsus resection

Frontal muscle flap

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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
Numbers of patients having dry eye syndrome
using OSDI test to see if patients have dry eye syndrome
Numbers of patients having corneal injury
corneal injury using topography to check
Numbers of patients having orbital insufficiency
orbital insufficiency, using new national standard visual acuity chart to test
Numbers of patients having conjunctival prolapse;
based on examination result using slit-lamp microscope
Numbers of patients having trichiasis;
based on examination result using slit-lamp microscope
Numbers of patients having eye infection;
based on examination result using slit-lamp microscope

Full Information

First Posted
April 8, 2019
Last Updated
April 12, 2019
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03916107
Brief Title
Comparison of Different Surgical Treatments for Severe Ptosis Correction
Official Title
Comparison of Different Surgical Treatments for Severe Ptosis Correction RCT Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis, Eyelid
Keywords
Ptosis, Frontalis flap

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levator muscle and tarsus resection
Arm Type
Experimental
Arm Title
Frontal muscle flap
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Levator muscle and tarsus resection
Intervention Description
Shortening the levator muscle with resection of tarsus to correct severe ptosis
Intervention Type
Procedure
Intervention Name(s)
Frontalis flap
Intervention Description
Using frontal muscle flap to correct severe ptosis
Primary Outcome Measure Information:
Title
levator muscle's strength
Description
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.
Time Frame
6 months post the treatment
Title
width of eyes
Description
Measure the width of eyes while doctor shall make sure patient avoid looking up or using the frontal muscle to lift eyelids.
Time Frame
6 months post the treatment
Title
MRD (margin reflex distance)
Description
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.
Time Frame
6 months post the treatment
Secondary Outcome Measure Information:
Title
Numbers of patients not completely corrected
Description
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
Time Frame
6 months post the treatment
Title
Numbers of patients having dry eye syndrome
Description
using OSDI test to see if patients have dry eye syndrome
Time Frame
6 months post the treatment
Title
Numbers of patients having corneal injury
Description
corneal injury using topography to check
Time Frame
6 months post the treatment
Title
Numbers of patients having orbital insufficiency
Description
orbital insufficiency, using new national standard visual acuity chart to test
Time Frame
6 months post the treatment
Title
Numbers of patients having conjunctival prolapse;
Description
based on examination result using slit-lamp microscope
Time Frame
6 months post the treatment
Title
Numbers of patients having trichiasis;
Description
based on examination result using slit-lamp microscope
Time Frame
6 months post the treatment
Title
Numbers of patients having eye infection;
Description
based on examination result using slit-lamp microscope
Time Frame
6 months post the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Yang, MD, Phd
Organizational Affiliation
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Different Surgical Treatments for Severe Ptosis Correction

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