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

NCT07003308 | Recruiting

• 1 other identifier: EC054-25_HRJC
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ptosis, Eyelid

Keywords

eyelid; levator palpebrae; oculoplastic surgery; ophthalmology; blepharoptosis

Outcome Measures

Primary Outcomes (1)

• Change in Marginal Reflex Distance 1 (MRD1) at 6 Months

  MRD1 will be measured preoperatively and at 6 months postoperatively to assess the difference in eyelid position between the anterior and posterior approach groups.

  Baseline (Day 0) and Month 6 (±2 weeks) after surgery

Secondary Outcomes (14)

• 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

Study Arms (2)

Anterior Approach Group

EXPERIMENTAL

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

Procedure: Anterior White Line Advancement Surgery

Posterior Approach Group

ACTIVE COMPARATOR

Participants will undergo upper eyelid ptosis correction using the posterior approach, which avoids skin incision and accesses the levator aponeurosis via the conjunctiva.

Procedure: Posterior White Line Advancement Surgery

Interventions

Anterior White Line Advancement Surgery PROCEDURE

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.

Anterior Approach Group

Posterior White Line Advancement Surgery PROCEDURE

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.

Posterior Approach Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Rey Juan Carlos Hospital

Móstoles, Madrid, 28932, Spain

RECRUITING

Related Publications (16)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34344132 BACKGROUND

• 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.

  PMID: 37522026 BACKGROUND

• 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.

  PMID: 28776587 BACKGROUND

• 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.

  PMID: 32733700 BACKGROUND

• 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.

  PMID: 35895522 BACKGROUND

• 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.

  PMID: 36692699 BACKGROUND

• 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.

  PMID: 33927356 BACKGROUND

• 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.

  PMID: 16234705 BACKGROUND

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Viviana Patricia Lezcano Carduz, MD

  Rey Juan Carlos Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviana Patricia Lezcano Carduz, MD

CONTACT

+34 914816225; viviana.lezcano@quironsalud.es

Francisco Javier González García, MD, PhD

CONTACT

+34 914816225; fjavier.gonzalez@hospitalreyjuancarlos.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: June 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)