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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Rey Juan Carlos Hospital
RECRUITING
Móstoles
Contact Information
Primary
Viviana Patricia Lezcano Carduz, MD
viviana.lezcano@quironsalud.es
+34 914816225
Backup
Francisco Javier González García, MD, PhD
fjavier.gonzalez@hospitalreyjuancarlos.es
+34 914816225
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 54
Treatments
Experimental: 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
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

This content was sourced from clinicaltrials.gov

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