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OpenTrials
Completed

NCT Number: NCT03217461

Corneal Autograft for Limbal Dermoid

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

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Key information

Conditions

Age range

5 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510070, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L,
  • Platelet levels < 150,000 or > 450,000 per microlite,
  • Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female),
  • Prothrombin time > 16s and activated partial thrombin time > 35s in patients not accepting anticoagulant therapy, An international normalized ratio greater than 3 in patients accepting anticoagulant therapy,
  • Pregnancy (positive test) or lactation,
  • Active immunological diseases,
  • Signs of current infection, including fever and treatment with antibiotics,
  • Participation in another simultaneous medical investigation or clinical trial.

Treatment and study plan

Limbal autograft

Procedure

Simple dermoid excision will be performed, followed by closure of the bare sclera and cornea by sutured femtosecond laser-assisted limbal autograft.

Femtosecond laser

Device

A commercial femtosecond laser to create a particular shaped graft for transplantation

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Best corrected visual acuity

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

    To measure best corrected visual acuity using ETDRS chart or Teller Acuity Cards.

  2. Corneal power, astigmatism and aberration

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

    To measure the changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.

  3. Cosmetic improvement

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

    A grading system from 0 to 4 with slit-lamp photographs will be used to determine cosmetic result of each graft.

Other outcomes

  1. Restoration of corneal surface

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

    Restoration of a completely epithelized, stable, and avascular corneal surface.

Sponsors and collaborators

Lead sponsor

Chunxiao Wang

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2017
Registry last updated
Jun 26, 2025

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.