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

University of Sao Paulo General Hospital

Status: Completed

Conditions: Lower Eyelid Retraction

Treatments: Procedure: Surgical correction of lower eyelid retraction using autogenous dermis graft spacer.; Procedure: Surgical correction of lower eyelid retraction using autologous cartilage

Study type: Interventional

Funder types: Other

Identifiers

NCT06679439

91414518.4.00000068

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Cartilage graft group

Active Comparator group

Description:

Patients with stable lower eyelid retraction that are submitted to surgical treatment using cartilage graft as spacer

Treatment:

Procedure: Surgical correction of lower eyelid retraction using autologous cartilage

Dermis graft group

Active Comparator group

Description:

Patients with stable lower eyelid retraction that are submitted to surgical treatment using dermis graft as spacer

Treatment:

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