Comparison of Dermis Vs. Auricular Cartilage Grafts for the Surgical Correction of Lower Eyelid Retraction

A Prospective, Randomized Comparison of Dermis Vs. Auricular Cartilage Grafts for the Surgical Correction of Lower Eyelid Retraction

This study aimed to compare the effectiveness of two autologous grafts-dermis and auricular cartilage-in the surgical correction of the lower eyelid retraction. Our primary focus was assessing changes in lower eyelid position using lower eyelid Margin to corneal Reflex Distance measurements, a.k.a Margin reflex distance 2 (MRD2).

Study Overview

• Status: Completed
• Conditions: Lower Eyelid Retraction
• Intervention / Treatment: Procedure: Surgical correction of lower eyelid retraction using autologous cartilage; Procedure: Surgical correction of lower eyelid retraction using autogenous dermis graft spacer.

Detailed Description

This prospective, randomized interventional study includes patients with stable LER. Patients are randomly assigned to undergo surgical correction using either auricular cartilage or dermis grafts, with the vertical dimension configured to be twice the scleral show height. MRD2 measurements were taken pre-operatively and at several post-operative intervals, with complications and outcomes recorded.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 01244
      • University of Sao Paulo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• eyelid retraction, scleral show

Exclusion Criteria:

• incomplete follow-up (less than 6 months), pregnancy and other abnormal ocular conditions or symptoms that preclude the patient's admission to the study, according to the clinical judgment of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cartilage graft group; Patients with stable lower eyelid retraction that are submitted to surgical treatment using cartilage graft as spacer	Procedure: Surgical correction of lower eyelid retraction using autologous cartilage; Surgical correction of lower eyelid retraction (LER) was performed using transcanthal cantopexy along with the insertion of an autogenous auricular cartilage graft spacer.
Active Comparator: Dermis graft group; Patients with stable lower eyelid retraction that are submitted to surgical treatment using dermis graft as spacer	Procedure: Surgical correction of lower eyelid retraction using autogenous dermis graft spacer.; Surgical correction of lower eyelid retraction (LER) was performed using transcanthal cantopexy along with the insertion of an autogenous dermis graft spacer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower eyelid Margin Reflex Distance measurements (MRD2) in millimeters	Data collected includes measurements of lower eyelid retraction using MRD2 from pre- and at 7 days, one month, three months, and six months' postoperative in facial frontal view photographs. Measurements are performed in a PC with Image J tool on digital photographs.	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Coordination for the Improvement of Higher Education Personnel

Publications and helpful links

Helpful Links

• Hospital site

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2018
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: eyelid; lower eyelid retraction
• Other Study ID Numbers: 91414518.4.00000068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: our results will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No