Ptosis, Eyelid
Conditions
Keywords
eyelid, levator palpebrae, oculoplastic surgery, ophthalmology, blepharoptosis
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.
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.
Sponsors
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Marginal Reflex Distance 1 (MRD1) at 6 Months | Baseline (Day 0) and Month 6 (±2 weeks) after surgery | MRD1 will be measured preoperatively and at 6 months postoperatively to assess the difference in eyelid position between the anterior and posterior approach groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Interpalpebral Symmetry at 2 and 6 Months | Month 2 (±1 week) and Month 6 (±2 weeks) after surgery | Symmetry between eyelids will be evaluated to assess aesthetic outcomes. |
| Eyelid Contour Evaluation at 2 and 6 Months | Month 2 (±1 week) and Month 6 (±2 weeks) after surgery | 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). |
| Change in Refractive Error at 2 and 6 Months | Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery | Comparison of pre- and postoperative refractive measurements. |
| Change in Corneal Topographic Parameters at 2 and 6 Months | Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery | Assessed using corneal topography to evaluate changes related to surgery. |
| Change in Tear Break-Up Time (TBUT) at 2 and 6 Months | Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery | Measured to assess the impact on tear film stability. TBUT will be measured by instilling fluorescein dye and recording the time (in seconds) from the last blink to the first appearance of a dry spot on the cornea. Each eye will be assessed three times, and the mean value will be used. Lower values indicate greater tear film instability. A TBUT \<10 seconds is considered abnormal. |
| Change in Schirmer Test (without anesthesia) at 2 and 6 Months | Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery | Evaluates tear production before and after surgery. The Schirmer I test (without anesthesia) measures basal and reflex tear production. Standardized strips will be placed in the lower fornix for 5 minutes. The length of wetting (in mm) will be recorded. Values \<10 mm indicate decreased tear production. |
| Change in MRD1 at 2 Months | Baseline (Day 0) and Month 2 (±1 week) after surgery | Measured preoperatively and at 2 months postoperatively to compare eyelid position between groups. |
| Change in Aesthetic Satisfaction Scores at 2 Months | Baseline (Day 0) and Month 2 (±1 week) after surgery | Assessed with the FACE-Q Aesthetics Satisfaction with Eyes scale. Raw scores are summed and converted to a 0-100 scale using the official Conversion Table. If ≥50% of items are answered, missing values are imputed using the within-person mean. Higher scores indicate greater satisfaction. |
| Change in Psychosocial Function Scores at 2 Months | Baseline (Day 0) and Month 2 (±1 week) after surgery | Patient-reported impact of surgery on self-image and social interaction. Measured using FACE-Q Aesthetics scales: Psychological Function, Social Function, and Appearance-Related Distress. Raw scores are summed and converted (0-100). Imputation is applied when ≥50% of items are answered. Higher scores reflect better outcomes, except for Distress, where higher scores indicate worse distress. |
| Assessment of Early Symptom Recovery at 7 Days | Day 7 (±1 day) after surgery | Evaluates discomfort, swelling, and return to normal activities. Assessed with FACE-Q Aesthetics scales for Recovery Early Symptoms and Eyelids-upper. Scoring follows standard FACE-Q procedure with 0-100 conversion. Missing values are imputed if ≥50% of items are answered. Higher scores reflect better recovery and appraisal. |
| Satisfaction with Surgical Outcome and Decision at 2 Months | Month 2 (±1 week) after surgery | Includes willingness to undergo the procedure again. Evaluated using FACE-Q Aesthetics scales: Satisfaction with Outcome and Satisfaction with Decision. Scores range from 0 (worst) to 100 (best). Missing data is managed per FACE-Q guidelines: impute mean values if ≥50% of items are completed. |
| Incidence of Surgical Complications Using Clavien-Dindo Classification | Day of surgery (Day 0), Day 7 (±1 day), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery | Surgical complications recorded intraoperatively, and at 7 days, 2 and 6 months. |
| Surgical Time Comparison | Day of surgery (Day 0); from operating room entry to exit (recorded in minutes) | Total duration of the surgical procedure, defined as the time elapsed from the patient's entry into the operating room until their exit after completion of surgery, will be recorded and compared between each surgery group. |
| Change in Ocular Surface Disease Index (OSDI) Scores at 7 Days, 2 and 6 Months | Baseline (Day 0), Day 7 (±1 day), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery | Patient-reported outcomes on dry eye symptoms. The OSDI questionnaire includes 12 items assessing symptoms, visual function, and environmental triggers. Raw scores are converted to a 0-100 scale using the formula: (sum of scores × 25) ÷ number of questions answered. Higher scores indicate greater symptom severity. Classification: 0-12 (normal), 13-22 (mild), 23-32 (moderate), ≥33 (severe). |
Countries
Spain
Contacts
Primary ContactViviana Patricia Lezcano Carduz, MD
Backup ContactFrancisco Javier González García, MD, PhD
Outcome results
None listed