NCT03217461

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
4.8 years until next milestone

Study Start

First participant enrolled

May 10, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2024

Completed
Last Updated

June 26, 2025

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

July 12, 2017

Last Update Submit

June 23, 2025

Conditions

Corneal Dermoid

Outcome Measures

Primary Outcomes (2)

  • Corneal Thickness

    To measure corneal thickness using anterior segment optical coherence tomography.

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

  • Corneal Transparency

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

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

Secondary Outcomes (3)

  • 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

Other Outcomes (1)

  • Restoration of corneal surface

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

Study Arms (1)

Limbal autograft

EXPERIMENTAL

Corneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft

Procedure: Limbal autograftDevice: Femtosecond laser

Interventions

Limbal autograftPROCEDURE

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

Limbal autograft
Femtosecond laserDEVICE

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

Limbal autograft

Eligibility Criteria

Age5 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510070, China

Location

Study Officials

  • Yizhi Liu, M.D.Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Ting Huang, M.D.Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical investigator

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 14, 2017

Study Start

May 10, 2022

Primary Completion

November 29, 2024

Study Completion

November 29, 2024

Last Updated

June 26, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)