Anterior Versus Posterior White Line Advancement Technique in the Correction of Aponeurotic Ptosis
NCT ID: NCT07003308
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2025-06-01
2027-01-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Responsible Party
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Viviana Patricia Lezcano Carduz
Principal Investigator.
Principal Investigators
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Viviana Patricia Lezcano Carduz, MD
Role: PRINCIPAL_INVESTIGATOR
Rey Juan Carlos Hospital
Locations
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Rey Juan Carlos Hospital
Móstoles, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Viviana Patricia Lezcano Carduz, Principal Investigator
Role: primary
Francisco Javier González García, Site Sub-Investigator
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
Mangan MS, Cakir A, Imamoglu S. Cumulative Sum Analysis of the Learning Curve of Ptosis Surgery: External Levator Advancement versus Muller Muscle-conjunctival Resection. Korean J Ophthalmol. 2021 Oct;35(5):383-390. doi: 10.3341/kjo.2021.0058. Epub 2021 Aug 3.
Arslan N, Bahar A, Acar M, Kosker M, Kabatas N, Gurdal C. The results of Muller Muscle Conjunctival Resection versus Levator Advancement for mild to moderate ptosis. Rom J Ophthalmol. 2023 Apr-Jun;67(2):128-133. doi: 10.22336/rjo.2023.23.
Antus Z, Salam A, Horvath E, Malhotra R. Outcomes for severe aponeurotic ptosis using posterior approach white-line advancement ptosis surgery. Eye (Lond). 2018 Jan;32(1):81-86. doi: 10.1038/eye.2017.128. Epub 2017 Aug 4.
Habroosh FA, Eatamadi H. Conjunctival Sparing Ptosis Correction by White-Line Advancement Technique. J Ophthalmol. 2020 Jul 15;2020:9021848. doi: 10.1155/2020/9021848. eCollection 2020.
Kim KK, Granick MS, Baum GA, Beninger F, Cahill KV, Donnelly KC, Kaidi AA, Kang AS, Loeding L, Loyo M, Patel PA, Roostaeian J, Taghva GH, Varkarakis GM. American Society of Plastic Surgeons Evidence-Based Clinical Practice Guideline: Eyelid Surgery for Upper Visual Field Improvement. Plast Reconstr Surg. 2022 Aug 1;150(2):419e-434e. doi: 10.1097/PRS.0000000000009329. Epub 2022 Jul 27.
Karam M, Alsaif A, Abul A, Alkhabbaz A, Alotaibi A, Shareef E, Behbehani R. Muller's muscle conjunctival resection versus external levator advancement for ptosis repair: systematic review and meta-analysis. Int Ophthalmol. 2023 Jul;43(7):2563-2573. doi: 10.1007/s10792-023-02633-1. Epub 2023 Jan 24.
Bacharach J, Lee WW, Harrison AR, Freddo TF. A review of acquired blepharoptosis: prevalence, diagnosis, and current treatment options. Eye (Lond). 2021 Sep;35(9):2468-2481. doi: 10.1038/s41433-021-01547-5. Epub 2021 Apr 29.
Kakizaki H, Zako M, Nakano T, Asamoto K, Miyaishi O, Iwaki M. The levator aponeurosis consists of two layers that include smooth muscle. Ophthalmic Plast Reconstr Surg. 2005 Sep;21(5):379-82.
Other Identifiers
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EC054-25_HRJC
Identifier Type: -
Identifier Source: org_study_id
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