Anterior versus posterior white line advancement for correcting drooping upper eyelids (ptosis)
Comparative Study of the Efficacy of Anterior Versus Posterior White Line Advancement Technique in the Correction of Primary Aponeurotic Ptosis
This study tests whether anterior or posterior white line advancement surgery better lifts and shapes upper eyelids in adults with primary aponeurotic ptosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Academic / other |
| Locations | 1 site (Móstoles, Madrid) |
| Trial ID | NCT07003308 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized 1:1 trial comparing two surgical approaches—anterior white line advancement through a skin crease incision and posterior white line advancement via a conjunctival incision—for primary aponeurotic upper eyelid ptosis. Participants receive one of the two procedures and are followed at 7 days, 2 months, and 6 months with objective eyelid position (MRD1), contour, and symmetry measurements, as well as vision and tear-film testing. Eyelid contour will be quantified using ImageJ with Bézier curve fitting and masked reviewers will provide subjective contour ratings, while patient-reported outcomes use the FACE-Q Aesthetics questionnaire. The primary outcome is change in MRD1 at 6 months, with secondary endpoints including contour, symmetry, patient satisfaction, and complication rates.
Who should consider this trial
Good fit: Adults over 18 with primary aponeurotic upper eyelid ptosis, levator function ≥12 mm, no prior ptosis surgery, and able to provide informed consent are ideal candidates.
Not a fit: People with non-aponeurotic ptosis, poor levator function, prior recurrent ptosis surgery, or other medical issues that preclude participation are unlikely to benefit from the results.
Why it matters
Potential benefit: If successful, the study could identify which technique gives better eyelid height, contour, and patient satisfaction with fewer complications, helping surgeons choose the optimal approach.
How similar studies have performed: Similar white line advancement techniques have reported good results in nonrandomized series, but randomized head-to-head comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Móstoles, Madrid
- Rey Juan Carlos Hospital — Móstoles, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Viviana Patricia Lezcano Carduz, MD — Rey Juan Carlos Hospital
- Study coordinator: Viviana Patricia Lezcano Carduz, MD
- Email: viviana.lezcano@quironsalud.es
- Phone: +34 914816225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.