RecruitingNot ApplicableNCT07003308

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

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


Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Enrollment

54 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age over 18 years.
  • Diagnosis of primary aponeurotic upper eyelid ptosis.
  • Levator muscle function of 12 mm or greater.
  • Provision of written informed consent after receiving adequate information about the study.

Exclusion Criteria6

  • Diagnosis of non-aponeurotic eyelid ptosis.
  • Poor levator muscle function.
  • History of recurrent eyelid ptosis or previous eyelid ptosis surgery.
  • Medical or surgical history that, in the investigator's judgment, may interfere with participation.
  • Individuals with childbearing potential who are not using highly effective contraception methods.
  • Refusal to participate in the study or to sign the informed consent form.

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Interventions

PROCEDUREAnterior White Line Advancement Surgery

This technique involves a skin incision at the eyelid crease, dissection through the orbicularis muscle to expose the tarsus, and proximal dissection in the pre-Müller-conjunctival plane to visualize the white line. A double-armed 5-0 absorbable suture is used to advance the white line to the anterior tarsal surface. Eyelid height and contour are assessed before final fixation. Skin closure is completed with a non-absorbable suture.

PROCEDUREPosterior White Line Advancement Surgery

This conjunctival technique uses a traction suture and eyelid eversion to access the posterior surface of the eyelid. A conjunctival incision is made above the superior tarsal border, followed by dissection to expose the white line. A double-armed 5-0 absorbable suture is passed through the anterior tarsus and the white line, and tied after confirming adequate eyelid position. The conjunctiva is not sutured.


Locations(1)

Rey Juan Carlos Hospital

Móstoles, Madrid, Spain

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NCT07003308


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