Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07003308

Anterior Versus Posterior White Line Advancement Technique in the Correction of Aponeurotic Ptosis

Led by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Updated on 2025-10-07

54

Participants Needed

1

Research Sites

86 weeks

Total Duration

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AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare the efficacy of two surgical techniques-anterior and posterior white line advancement-for the correction of primary aponeurotic ptosis in adult patients. The main questions it aims to answer are: Does the anterior approach lead to a greater improvement in Marginal Reflex Distance 1 (MRD1) at 6 months compared to the posterior approach? Are there differences in eyelid symmetry, contour, visual function, and patient satisfaction between the two techniques? Researchers will compare the anterior approach group to the posterior approach group to see if one offers better functional and aesthetic outcomes, fewer complications, or higher patient satisfaction. Participants will: Be randomly assigned to receive either anterior or posterior white line advancement surgery. Undergo preoperative and postoperative evaluations at 7 days, 2 months, and 6 months, including: Measurements of eyelid position (MRD1), contour, and symmetry Vision and tear film tests (e.g., refraction, TBUT, Schirmer's test) Surveys on dry eye symptoms (OSDI), scar quality (POSAS 2.0), satisfaction, and psychosocial function Monitoring of surgical time and complications

CONDITIONS

Official Title

Anterior Versus Posterior White Line Advancement Technique in the Correction of Aponeurotic Ptosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Diagnosis of primary aponeurotic upper eyelid ptosis
  • Levator muscle function of 12 mm or greater
  • Provided written informed consent after receiving adequate study information
Not Eligible

You will not qualify if you...

  • Diagnosis of non-aponeurotic eyelid ptosis
  • Poor levator muscle function
  • History of recurrent eyelid ptosis or previous eyelid ptosis surgery
  • Medical or surgical history interfering with participation as judged by the investigator
  • Individuals with childbearing potential not using highly effective contraception
  • Refusal to participate or sign informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Rey Juan Carlos Hospital

Móstoles, Madrid, Spain, 28932

Actively Recruiting

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Research Team

V

Viviana Patricia Lezcano Carduz, MD

CONTACT

F

Francisco Javier González García, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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