Anterior Versus Posterior White Line Advancement Technique in the Correction of Aponeurotic Ptosis (NCT07003308) | Clinical Trial Compass
RecruitingNot Applicable
Anterior Versus Posterior White Line Advancement Technique in the Correction of Aponeurotic Ptosis
Spain54 participantsStarted 2025-06-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Marginal Reflex Distance 1 (MRD1) at 6 Months
Timeframe: Baseline (Day 0) and Month 6 (±2 weeks) after surgery
Trial details
NCT IDNCT07003308
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz