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

NCT06679439 | Completed

• 1 other identifier: 91414518.4.00000068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lower Eyelid Retraction

Keywords

eyelid; lower eyelid retraction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cartilage graft group

ACTIVE COMPARATOR

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

Dermis graft group

ACTIVE COMPARATOR

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.

Interventions

Surgical correction of lower eyelid retraction using autologous cartilage PROCEDURE

Surgical correction of lower eyelid retraction (LER) was performed using transcanthal cantopexy along with the insertion of an autogenous auricular cartilage graft spacer.

Cartilage graft group

Surgical correction of lower eyelid retraction using autogenous dermis graft spacer. PROCEDURE

Surgical correction of lower eyelid retraction (LER) was performed using transcanthal cantopexy along with the insertion of an autogenous dermis graft spacer.

Dermis graft group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eyelid retraction, scleral show

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 01244, Brazil

Location

Related Links

• Hospital site

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 7, 2024
• Study Start: February 7, 2018
• Primary Completion: September 30, 2023
• Study Completion: May 22, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)