Tiba Eye Center
Asyut, 71516, Egypt
NCT Number: NCT06267495
Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists.
The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only.
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Notify Me12 year–30 year
All sexes
Observational
Asyut, 71516, Egypt
Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease associated with corneal thinning and protrusion with resultant irregular astigmatism and visual loss.
Although several studies showed that epithelium-off corneal cross-linking (epi-off CXL) is more effective in preventing KC progression compared with epithelium-on corneal cross-linking (epi-on CXL), the removal of corneal epithelium in epi-off CXL might be associated with a number of serious complications such as persistent epithelial defects and sight-threatening infectious keratitis. Additionally, recent systematic reviews and meta-analysis concluded that epi-on CXL is as effective as epi-off CXL in terms of visual and topographic stability of keratoconus, but has the advantage of being much safer avoiding the complications of epithelial removal.
The management of the better eye, of young patients with unilateral clinically evident KC, is controversial. Some ophthalmologists prefer to cross-link the better eye, while others prefer to conservatively follow it up, in order to avoid complications of epithelial removal in epi-off CXL.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients aged 12 to 30 years presented with forme fruste (FFKC) or subclinical KC, based on the following criteria:
Exclusion criteria
In epithelium-on corneal cross-linking (epi-on CXL), the cornea is soaked with riboflavin for 10 minutes (Paracel® for 4 minutes and VibeX-xtra® for 6 minutes) . Thereafter, the cornea is subjected to ultraviolet A at a wavelength of 370 nm to give a total dose of 5.4 J/cm² through 10 milliwatt mW/cm² for 9 minutes.
Time frame: 24 months
The steep keratometry is measured using pentacam. A higher value means a worse outcome.
Time frame: 24 months
The maximum keratometry is measured using pentacam. A higher value means a worse outcome.
Time frame: 24 months
Corrected distance visual acuity (CDVA) is measured with Snellen's acuity chart and converted to logarithm of the minimum angle of resolution (logMAR) notation.
The higher the logMAR CDVA, the worse the outcome.
Assiut University
Other
Epithelium-on Accelerated Corneal Cross-linking Versus Observation of Fellow Eyes of Young Patients With Unilateral Clinically Evident Keratoconus
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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.
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