Clinical trial NCT07003308: Anterior Versus Posterior White Line Advancement Technique in the Correction of Aponeurotic Ptosis
Official title: Comparative Study of the Efficacy of Anterior Versus Posterior White Line Advancement Technique in the Correction of Primary Aponeurotic Ptosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ptosis, Eyelid
Keywords: eyelid
levator palpebrae
oculoplastic surgery
ophthalmology
blepharoptosis
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This is a prospective, randomized, controlled clinical trial designed to compare the efficacy, functional outcomes, aesthetic results, and patient-reported satisfaction associated with two surgical techniques for correcting primary aponeurotic ptosis: anterior white line advancement and posterior white line advancement.

Participants will be randomized 1:1 into two parallel groups. In the anterior approach, access to the levator aponeurosis is achieved via a skin crease incision, and advancement is performed using sutures placed on the white line to reattach it to the anterior surface of the tarsus. In the posterior approach, access is gained through a conjunctival incision above the superior tarsal border, followed by dissection to expose the white line and suture advancement to the anterior tarsus, without a skin incision.

Functional eyelid position will be assessed through MRD1 measurements, symmetry evaluation, and contour analysis. Contour will be quantified objectively using ImageJ software with Bézier curve fitting, and subjectively through independent masked evaluations based on pre-defined criteria.

Patient-reported outcomes will be assessed using the validated FACE-Q Aesthetics questionnaire, including scales for appearance satisfaction, psychosocial function, early recovery, and satisfaction with the surgical outcome and decision. Tear film stability and ocular surface parameters will be assessed using TBUT, Schirmer test (without anesthesia), and the Ocular Surface Disease Index (OSDI).

Standardized digital photographs will be taken at each follow-up visit to ensure consistent evaluation of eyelid contour and aesthetic results. All images and clinical data will be securely stored with restricted access for authorized investigators only.

Follow-up visits are scheduled for Day 7, Month 2, and Month 6 postoperatively. No masking will be applied due to the nature of the surgical techniques; however, outcome assessors for eyelid contour and patient-reported measures will remain blinded to group assignment.

This study aims to generate high-quality comparative data to guide clinical decision-making in the surgical management of aponeurotic ptosis, with an emphasis on both anatomical and patient-centered outcomes.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Marginal Reflex Distance 1 (MRD1) at 6 Months
timeFrame: Baseline (Day 0) and Month 6 (±2 weeks) after surgery
Secondary outcomes:
measure: Change in MRD1 at 2 Months
timeFrame: Baseline (Day 0) and Month 2 (±1 week) after surgery
measure: Postoperative Interpalpebral Symmetry at 2 and 6 Months
timeFrame: Month 2 (±1 week) and Month 6 (±2 weeks) after surgery
measure: Eyelid Contour Evaluation at 2 and 6 Months
timeFrame: Month 2 (±1 week) and Month 6 (±2 weeks) after surgery
measure: Change in Refractive Error at 2 and 6 Months
timeFrame: Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery
measure: Change in Corneal Topographic Parameters at 2 and 6 Months
timeFrame: Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery
measure: Change in Tear Break-Up Time (TBUT) at 2 and 6 Months
timeFrame: Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery
measure: Change in Schirmer Test (without anesthesia) at 2 and 6 Months
timeFrame: Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery
measure: Change in Ocular Surface Disease Index (OSDI) Scores at 7 Days, 2 and 6 Months
timeFrame: Baseline (Day 0), Day 7 (±1 day), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery
measure: Change in Aesthetic Satisfaction Scores at 2 Months
timeFrame: Baseline (Day 0) and Month 2 (±1 week) after surgery
measure: Change in Psychosocial Function Scores at 2 Months
timeFrame: Baseline (Day 0) and Month 2 (±1 week) after surgery
measure: Assessment of Early Symptom Recovery at 7 Days
timeFrame: Day 7 (±1 day) after surgery
measure: Satisfaction with Surgical Outcome and Decision at 2 Months
timeFrame: Month 2 (±1 week) after surgery
measure: Incidence of Surgical Complications Using Clavien-Dindo Classification
timeFrame: Day of surgery (Day 0), Day 7 (±1 day), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery
measure: Surgical Time Comparison
timeFrame: Day of surgery (Day 0); from operating room entry to exit (recorded in minutes)
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: Rey Juan Carlos Hospital
state: Madrid
Study officials:
affiliation: Rey Juan Carlos Hospital
name: Viviana Patricia Lezcano Carduz, MD
role: PRINCIPAL_INVESTIGATOR
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