An interventional study of Corneal donors predisposed by CXL and Corneal donors stored in corneal storage media in Keratoconus, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
Keratoconus is a progressive ecstatic corneal disease characterized by forward bulging of the cornea, thinning of the corneal stroma, and irregular astigmatism. Corneal transplantation is necessary for patients with advanced keratoconus when spectacles and contact lens are inadequate for visual correction. Deep anterior lamellar keratoplasty is a conventional procedure for the treatment of keratoconus. However, DALK itself frequently causes abnormality of refraction, such as high degrees of astigmatism owing to irregular corneal surface for keratoconic eyes. Possible mechanisms of this progressive astigmatism include the recurrence of keratoconus in the grafts, progressive corneal thinning of the host cornea, or progressive misalignment of the graft- host interface over time, which prevents the achievement of satisfactory vision.
Corneal collagen cross-linking is believed to have the ability to halt or decrease the progression of keratoconus. CXL treats keratoconus by strengthening corneal stromal collagen bonds with riboflavin activated by ultraviolet A (UVA), and is now a first-line treatment for progressive keratoconus. In this randomized controlled trial, we performed CXL on corneal donor tissues with the aim of achieving corneal stromal stiffening, thereafter DALK was conducted for the patients with advanced keratoconus using the tissues predisposed by CXL. The goal of this study is evaluating whether the strengthening grafts could reduce postoperative myopic refractive errors or arrest the progression of keratoconus for the patients with DALK.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 70 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Corneal donors predisposed by CXL were used and the conventional DALK procedure was conducted in patients
Procedure: Corneal donors predisposed by CXL
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
Corneal donors predisposed by CXL and DALK procedure was conducted in patients
Corneal donors stored in corneal storage media and DALK procedure was conducted in patients
Simulated keratometry
Simulated keratometry measured by topography
Time frame: up to 36 months
Uncorrected distance visual acuity（UDVA）
UDVA (by using Snellen acuity charts) before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time frame: 36 months
Corrected distance visual acuity （CDVA）
CDVA (by using Snellen acuity charts) before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time frame: 36 months
Spherical equivalent (SE)
SE will be detected by combined optometry and phoroptor refractometer before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time frame: 36 months
Manifest cylinder
Manifest cylinder will be detected by topography before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time frame: 36 months
Corneal thickness
Corneal thickness of the thinnest area will be detected by Optical Coherence tomography before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Time frame: 36 months
Corneal endothelium cells
Corneal endothelium cells will be detected by confocal microscopy before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24 ,30 and 36 months after surgery
Time frame: 36 months
Intraocular pressure
Intraocular pressure was measured by non-contact tonometer before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24,30 and 36 months after surgery
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhongshan Ophthalmic Center, Sun Yat-sen University