Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07003308

Comparative Study of the Efficacy of Anterior Versus Posterior White Line Advancement Technique in the Correction of Primary Aponeurotic Ptosis

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

54

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two surgical techniques, anterior and posterior white line advancement, for correcting primary aponeurotic ptosis in adults. The study seeks to determine if the anterior approach improves eyelid position, measured by Marginal Reflex Distance 1 (MRD1), better at 6 months than the posterior approach. It also evaluates differences in eyelid symmetry, contour, vision, and patient satisfaction between the two methods. Participants will be randomly assigned to one of two groups: one receiving the anterior approach involving a skin crease incision to access and advance the levator aponeurosis, and the other receiving the posterior approach, which uses a conjunctival incision without a skin cut. Both surgeries involve advancing the white line to the anterior tarsus using sutures. The study includes follow-up visits at 7 days, 2 months, and 6 months after surgery. During these visits, researchers will measure eyelid position and symmetry, evaluate eyelid contour using both software and masked evaluators, and test vision and tear film stability. Patients will also complete surveys on dry eye symptoms, scar quality, satisfaction, and psychosocial function. Surgical time and complications will be monitored. All images and data will be securely stored, and outcome assessors will be blinded to the group assignments for certain evaluations.

CONDITIONS

Brief 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
  • Written informed consent provided after receiving 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 investigator
  • Individuals with childbearing potential not using highly effective contraception
  • Refusal to participate or sign informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day 0

Participants undergo surgical correction of aponeurotic ptosis using either the anterior or posterior white line advancement technique. Eyelid height and contour are assessed during surgery. Immediate post-operative care follows the procedure.

1 visit (in-person)

Post-operative Follow-up

Duration - 7 days to 6 months after surgery

Participants attend follow-up visits to assess eyelid position, contour, ocular surface health, and patient-reported outcomes including satisfaction and psychosocial function.

3 visits (Day 7, Month 2, and Month 6 post-surgery, in-person)

Trial Site Locations

Total: 1 location

1

Rey Juan Carlos Hospital

Móstoles, Madrid, Spain, 28932

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Research Team

V

Viviana Patricia Lezcano Carduz, MD

F

Francisco Javier González García, MD, PhD

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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Published Research Related To This Trial

Digital analysis of unilateral ptosis repair: external levator advancement vs. Müller's muscle conjunctival resection.

Serdar Bilici, Tomurcuk Harbigil-Sever, Suat Hayri Ugurbas

https://pubmed.ncbi.nlm.nih.gov/38537045

Cumulative Sum Analysis of the Learning Curve of Ptosis Surgery: External Levator Advancement versus Müller Muscle-conjunctival Resection.

Mehmet Serhat Mangan, Akin Cakir, Serhat Imamoglu

https://pubmed.ncbi.nlm.nih.gov/34344132