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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-07

Study Completion Date

2024-05-22

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lower Eyelid Retraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no masking

Study Groups

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Cartilage graft group

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

Group Type ACTIVE_COMPARATOR

Surgical correction of lower eyelid retraction using autologous cartilage

Intervention Type PROCEDURE

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

Dermis graft group

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No