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

NCT07003308 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-10-07

No results posted yet for this study

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

Conditions

  • Ptosis, Eyelid

Interventions

PROCEDURE

Anterior 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.

PROCEDURE

Posterior 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.

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Viviana Patricia Lezcano Carduz, MD · Rey Juan Carlos Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-12-30
Completion
2027-01-30

Countries

  • Spain

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 NCT07003308 on ClinicalTrials.gov