Comparative Study of the Efficacy of Anterior Versus Posterior White Line Advancement Technique in the Correction of Primary Aponeurotic Ptosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Marginal Reflex Distance 1 (MRD1) at 6 Months
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Anterior Approach Group
Participants will undergo upper eyelid ptosis correction using the anterior approach, involving a skin incision through the upper eyelid crease to access the levator aponeurosis
干预措施: Anterior White Line Advancement Surgery (Procedure)
Posterior Approach Group
Participants will undergo upper eyelid ptosis correction using the posterior approach, which avoids skin incision and accesses the levator aponeurosis via the conjunctiva.
干预措施: Posterior White Line Advancement Surgery (Procedure)
结局指标
主要结局
Change in Marginal Reflex Distance 1 (MRD1) at 6 Months
时间窗: 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.
次要结局
- Change in MRD1 at 2 Months(Baseline (Day 0) and Month 2 (±1 week) after surgery)
- Postoperative Interpalpebral Symmetry at 2 and 6 Months(Month 2 (±1 week) and Month 6 (±2 weeks) after surgery)
- Eyelid Contour Evaluation at 2 and 6 Months(Month 2 (±1 week) and Month 6 (±2 weeks) after surgery)
- Change in Refractive Error at 2 and 6 Months(Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery)
- Change in Corneal Topographic Parameters at 2 and 6 Months(Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after 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)
- 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)
- 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)
- Change in Aesthetic Satisfaction Scores at 2 Months(Baseline (Day 0) and Month 2 (±1 week) after surgery)
- Change in Psychosocial Function Scores at 2 Months(Baseline (Day 0) and Month 2 (±1 week) after surgery)
- Assessment of Early Symptom Recovery at 7 Days(Day 7 (±1 day) after surgery)
- Satisfaction with Surgical Outcome and Decision at 2 Months(Month 2 (±1 week) after surgery)
- 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 Time Comparison(Day of surgery (Day 0); from operating room entry to exit (recorded in minutes))
研究者
Viviana Patricia Lezcano Carduz
Principal Investigator.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz