Comparison of Different Surgical Treatments for Severe Ptosis Correction

NCT03916107 | Unknown

• 1 other identifier: 2018-81-T72
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ptosis, Eyelid

Keywords

Ptosis; Frontalis flap

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Numbers of patients not completely corrected

  6 months post the treatment

• Numbers of patients having dry eye syndrome

  6 months post the treatment

• Numbers of patients having corneal injury

  6 months post the treatment

• Numbers of patients having orbital insufficiency

  6 months post the treatment

• Numbers of patients having conjunctival prolapse;

  6 months post the treatment

Study Arms (2)

Levator muscle and tarsus resection

EXPERIMENTAL

Procedure: Levator muscle and tarsus resection

Frontal muscle flap

ACTIVE COMPARATOR

Procedure: Frontalis flap

Interventions

Levator muscle and tarsus resection PROCEDURE

Shortening the levator muscle with resection of tarsus to correct severe ptosis

Levator muscle and tarsus resection

Frontalis flap PROCEDURE

Using frontal muscle flap to correct severe ptosis

Frontal muscle flap

Eligibility Criteria

• Age: 3 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral ptosis patient
• the levator muscle strength less than 4mm
• primary surgery
• older than 3 years
• ocular rectus muscle of good strength;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Jun Yang, MD, Phd

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 16, 2019
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)