NCT05905978

Brief Summary

The Study was designed as a randomized controlled study with the following objectives: To investigate whether use of donors predisposed by corneal collagen cross-linking (CXL) reduced myopic refractive errors for keratoconic eyes after Deep anterior lamellar keratoplasty (DALK). Overall 70 patients are planned to recruit., the patients were assigned to CXL graft group, in which corneal donors predisposed by CXL were used, or the conventional graft group, in which corneal donors stored in corneal storage media were used. The patients will be followed-up for 24 months.

Trial Health

63
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Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress73%
Jun 2023Jul 2027

Study Start

First participant enrolled

June 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 15, 2023

Status Verified

May 1, 2023

Enrollment Period

3.1 years

First QC Date

June 2, 2023

Last Update Submit

June 14, 2023

Conditions

Keratoconus

Keywords

Corneal collagen cross-linkingDeep lamellar keratoplastyKeratoconus

Outcome Measures

Primary Outcomes (1)

  • Simulated keratometry

    Simulated keratometry measured by topography

    up to 36 months

Secondary Outcomes (7)

  • Uncorrected distance visual acuity（UDVA）

    36 months

  • Corrected distance visual acuity （CDVA）

    36 months

  • Spherical equivalent (SE)

    36 months

  • Manifest cylinder

    36 months

  • Corneal thickness

    36 months

  • +2 more secondary outcomes

Study Arms (2)

CXL graft group

EXPERIMENTAL

Corneal donors predisposed by CXL were used and the conventional DALK procedure was conducted in patients

Procedure: Corneal donors predisposed by CXL

Conventional graft group

ACTIVE COMPARATOR

Corneal donors stored in corneal storage media were used and the conventional DALK procedure was conducted in patients

Procedure: Corneal donors stored in corneal storage media

Interventions

Corneal donors predisposed by CXLPROCEDURE

Corneal donors predisposed by CXL and DALK procedure was conducted in patients

CXL graft group
Corneal donors stored in corneal storage mediaPROCEDURE

Corneal donors stored in corneal storage media and DALK procedure was conducted in patients

Conventional graft group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The best corrected visual quality of frame glasses is less than 0.3，2.The best corrected visual quality of rigid gas permeable contact lens (RGPCL) is less than 0.5/ RGPCL intolerance，3.The anterior corneal surface curvature \>55D，4.The thinnest corneal thickness is less than 400 μm. One of the above four items is met
  • Patients must be willing and able to return for scheduled follow-up examinations for 36 months after surgery
  • Ages：over 18 Years

You may not qualify if:

  • History of intraocular surgery
  • Severe dry eye
  • Severe eyelid and conjunctival scar
  • Loss of vision in contralateral eye
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510070, China

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

Ting Huang, MD, PHD

CONTACT

86-13682205425thuang@vip.163.com

Xiaojuan Dong, MD, PHD

CONTACT

86-13552338050qingerdong@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 15, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

June 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)