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Completed

NCT Number: NCT06679439

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).

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Key information

Conditions

Lower Eyelid Retraction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo General Hospital

São Paulo, 01244, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Lower eyelid Margin Reflex Distance measurements (MRD2) in millimeters

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Coordination for the Improvement of Higher Education Personnel

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Nov 7, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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