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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anterior White Line Advancement Surgery

    Procedure/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.

  • Posterior White Line Advancement Surgery

    Procedure/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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Anterior Approach GroupExperimental treatment 1 intervention
Group B: Posterior Approach GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Marginal Reflex Distance 1 (MRD1) at 6 Months

MRD1 will be measured preoperatively and at 6 months postoperatively to assess the difference in eyelid position between the anterior and posterior approach groups.

Time frame
Baseline (Day 0) and Month 6 (±2 weeks) after surgery

Secondary outcomes

1

Change in MRD1 at 2 Months

Measured preoperatively and at 2 months postoperatively to compare eyelid position between groups.

Time frame
Baseline (Day 0) and Month 2 (±1 week) after surgery
2

Postoperative Interpalpebral Symmetry at 2 and 6 Months

Symmetry between eyelids will be evaluated to assess aesthetic outcomes.

Time frame
Month 2 (±1 week) and Month 6 (±2 weeks) after surgery
3

Eyelid Contour Evaluation at 2 and 6 Months

Eyelid contour will be assessed using standardized frontal photographs in primary gaze. Objective analysis will be performed with ImageJ software using the Bézier plugin to calculate the percentage of overlap with an ideal curve (Excellent: \>90%, Good: 85-90%, Poor: \<85%). Subjective assessment will be conducted by three masked investigators based on symmetry, curvature, and slope criteria, rated as Excellent (3/3), Good (2/3), or Poor (0-1/3).

Time frame
Month 2 (±1 week) and Month 6 (±2 weeks) after surgery
4

Change in Refractive Error at 2 and 6 Months

Comparison of pre- and postoperative refractive measurements.

Time frame
Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery

Other outcomes

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