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Comparison of Different Surgical Treatments for Severe Ptosis Correction

NCT03916107 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-04-16

No results posted yet for this study

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

Interventions

PROCEDURE

Levator muscle and tarsus resection

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

PROCEDURE

Frontalis flap

Using frontal muscle flap to correct severe ptosis

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916107 on ClinicalTrials.gov