Anterior Versus Posterior White Line Advancement Technique in the Correction of Aponeurotic Ptosis

Официальное название

Comparative Study of the Efficacy of Anterior Versus Posterior White Line Advancement Technique in the Correction of Primary Aponeurotic Ptosis

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура Anterior 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.
• Процедура Posterior 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.

Первичные конечные точки

• Change in Marginal Reflex Distance 1 (MRD1) at 6 Months [Срок оценки: Baseline (Day 0) and Month 6 (±2 weeks) after surgery]

Вторичные конечные точки (12)

• Change in MRD1 at 2 Months [Срок оценки: Baseline (Day 0) and Month 2 (±1 week) after surgery]
• Postoperative Interpalpebral Symmetry at 2 and 6 Months [Срок оценки: Month 2 (±1 week) and Month 6 (±2 weeks) after surgery]
• Eyelid Contour Evaluation at 2 and 6 Months [Срок оценки: Month 2 (±1 week) and Month 6 (±2 weeks) after surgery]
• Change in Refractive Error at 2 and 6 Months [Срок оценки: Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery]
• Change in Corneal Topographic Parameters at 2 and 6 Months [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (Day 0) and Month 2 (±1 week) after surgery]
• Change in Psychosocial Function Scores at 2 Months [Срок оценки: Baseline (Day 0) and Month 2 (±1 week) after surgery]
• Assessment of Early Symptom Recovery at 7 Days [Срок оценки: Day 7 (±1 day) after surgery]
• Satisfaction with Surgical Outcome and Decision at 2 Months [Срок оценки: Month 2 (±1 week) after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Rey Juan Carlos Hospital — Móstoles

Публикации

• Shen Y, Yu W, Ding F, Lu L, Liu F, Sun D, Luo X, Jin R, Yang J. Aesthetic Correction of Mild-to-Moderate Blepharoptosis Among Asians: The Bridge Technique. Ophthalmol Ther. 2022 Feb;11(1):151-160. doi: 10.1007/s40123-021-00417-3. Epub 2021 Nov 6. PMID 34741757
• Ozturk Karabulut G, Fazil K. Corneal Topographical Changes After Muller's Muscle-conjunctival Resection Surgery. Ophthalmic Plast Reconstr Surg. 2019 Mar/Apr;35(2):177-181. doi: 10.1097/IOP.0000000000001203. PMID 30130332
• Inal Ozen M, Demirok G, Yalniz Akkaya Z, Akbas Kocaoglu F, Katircioglu Y, Celik T, Ornek F, Acar DD. Effect of upper eyelid blepharoplasty surgery on cornea biomechanics and ocular surface. Int Ophthalmol. 2024 Sep 22;44(1):386. doi: 10.1007/s10792-024-03313-4. PMID 39306627
• Aksu Ceylan N, Yeniad B. Effects of Upper Eyelid Surgery on the Ocular Surface and Corneal Topography. Turk J Ophthalmol. 2022 Feb 23;52(1):50-56. doi: 10.4274/tjo.galenos.2021.63255. PMID 35196840
• Bilici S, Harbigil-Sever T, Ugurbas SH. Digital analysis of unilateral ptosis repair: external levator advancement vs. Muller's muscle conjunctival resection. Arq Bras Oftalmol. 2024 Mar 22;87(3):e20230028. doi: 10.5935/0004-2749.2023-0028. eCollection 2024. PMID 38537045
• Schulz CB, Nicholson R, Penwarden A, Parkin B. Anterior approach white line advancement: technique and long-term outcomes in the correction of blepharoptosis. Eye (Lond). 2017 Dec;31(12):1716-1723. doi: 10.1038/eye.2017.138. Epub 2017 Aug 11. PMID 28799556
• Patel V, Salam A, Malhotra R. Posterior approach white line advancement ptosis repair: the evolving posterior approach to ptosis surgery. Br J Ophthalmol. 2010 Nov;94(11):1513-8. doi: 10.1136/bjo.2009.172353. Epub 2010 Sep 10. PMID 20833687
• Sagili S. Anterior Approach White-Line Advancement: A Hybrid Technique for Ptosis Correction. Ophthalmic Plast Reconstr Surg. 2015 Nov-Dec;31(6):478-81. doi: 10.1097/IOP.0000000000000543. PMID 26325380

Идентификаторы

NCT: NCT07003308 · EC054-25_HRJC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗