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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06679439
Enrollment
30
Registered
2024-11-07
Start date
2018-02-07
Completion date
2024-05-22
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Eyelid Retraction

Keywords

eyelid, lower eyelid retraction

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).

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.

Interventions

PROCEDURESurgical 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.

PROCEDURESurgical 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.

Sponsors

Coordination for the Improvement of Higher Education Personnel
CollaboratorOTHER
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

no masking

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lower eyelid Margin Reflex Distance measurements (MRD2) in millimeters6 monthsData 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026