Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for the Patients With Keratoconus

NCT05905978 · tracked via the Priya Life Science China tracker

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Phase

Not applicable

Started

2023-06

Last updated

2023-06-15

Condition(s) studied

Keratoconus

Investigational drug(s) / intervention(s)

Corneal donors predisposed by CXLCorneal donors stored in corneal storage media

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * 1.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 Exclusion Criteria: * History of intraocular surgery * Severe dry eye * Severe eyelid and conjunctival scar * Loss of vision in contralateral eye * Pregnant and lactating women

Primary outcome measure(s)

Simulated keratometry — up to 36 months
Simulated keratometry measured by topography

Trial sites (1)

Facility	City	Region	Status
Zhongshan Ophthalmic Center, Sun Yat-Sen University	Guangzhou	Guangdong

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Other trials for the same condition

A Study of a Novel Scheimpflug Device in Diagnosing Keratoconus Active, not recruiting

Clinical and Subclinical Keratoconus Cohort Study Starting soon

The K-Map Study, Global Prevalence of KC Recruiting

The Collagen Factors of Rapid Progression of Keratoconus in Children. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05905978 on ClinicalTrials.gov ↗ ← All trials in China