A Non-randomized Controlled Clinical Trial of Corneal Autograft for Limbal Dermoid

Chunxiao Wang1 site in 1 country19 target enrollmentMay 10, 2022

Overview

To investigate the clinical efficacy of femtosecond laser-assisted autologous lamellar keratoplasty in treating corneal dermoids.

Registry

clinicaltrials.gov

Start Date

May 10, 2022

End Date

November 29, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Chunxiao Wang

Responsible Party

Sponsor Investigator

Principal Investigator

Chunxiao Wang

Clinical investigator

Sun Yat-sen University

•Age between 5 to 35 years old,
•Patients with limbal dermoid, scheduled for elective surgical excision,
•The distance of less than 5 mm of lesion encroachment into the cornea,
•The participant or their legal guardian has voluntarily chosen to participate in this study, has signed the informed consent form, and has demonstrated a high level of adherence to the study protocols and cooperation throughout the follow-up process.

•Keratoconus,
•High myopia with a spherical equivalent of -15.0 D or less,
•Ocular and facial active inflammation such as keratitis, trachoma, dacryocystitis, blepharitis, meibomian gland dysfunction, Sjogren's syndrome, cicatricial pemphigoid etc,
•Corneal or ocular surface infection within 30 days prior to study entry,
•Severe cicatricial eye disease,
•Ocular surface malignancy,
•Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases,
•History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries,
•Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%,
•Renal failure with creatinine clearance\< 25ml/min,

Corneal Thickness

Time Frame: 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively

To measure corneal thickness using anterior segment optical coherence tomography.

Corneal Transparency

Time Frame: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively

The transparency and appearance of the cornea will be observed using slit-lamp microscopy

Best corrected visual acuity(Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively)
Corneal power, astigmatism and aberration(Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively)
Cosmetic improvement(Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively)