Tiba eye center
Asyut, 71516, Egypt
NCT Number: NCT05693740
To evaluate and compare the effect of pulsed light (pl-ACXL) accelerated and continuous light accelerated (cl-ACXL) epithelium-off cross-linking in halting the progression of keratoconus.
Looking for future studies?
Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Asyut, 71516, Egypt
Keratoconus (KC), which was first described in detail in 1854, is the most common corneal primary ectasia and is characterized by progressive bilateral and asymmetric corneal thinning and bulging outward into a cone-like shape that can severely impact patients' vision.
Keratoconus usually develops in the second and third decades of life and progresses until the fourth decade. It was thought to be a rare corneal disease.
Despite a great deal of research, no one theory explains it all and it may be caused by a combination of things. However, Meek proposed that the loss of structural integrity in the KC cornea was caused by the presence of abnormal keratocytes and matrix proteins and upregulated proteolysis triggered an unravelling of lamellae along their length and from their anchors at the limbus, with an opening of the lamellar bifurcations. This theory is supported by observations following riboflavin/UVA collagen cross-linking, where the proposed cross-linkage of the tissue increases both the resistance of the stroma to enzymatic digestion and the cohesiveness between collagen fibrils and the non-collagenous matrix.
Conventional CXL (CXL) with a continuous irradiation of 3 mW/cm2 for 30 min is considered safe and effective in the prevention of keratoconus progression according to different clinical trials. nevertheless, the procedure is time-consuming, lasting around 1 h, which may lead to patient discomfort and reduced physician working efficiency.
With evolving technical advances, commercially available UV light sources have been developed, making CXL more efficient with shorter UV exposure times, higher UV intensities, and pulsed light compared with continuous light settings. Various accelerated CXL protocols have been described and its effect on biomechanical properties on corneas stated as equal to the standard protocol. Ex-vivo studies also suggest a distinction between various accelerated CXL protocols by providing evidence for a drop in efficiency with increased UV illumination intensity while maintaining equal surface energy. In this study we evaluate the two types of "accelerated crosslinking".
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Increase of 1.0D or more in the manifest cylinder Increase of 0.5D or more in the manifest refraction spherical equivalent Increase of 1.0D or more in Kmax Increase of 0.75D or more in Kmean decrease of 2% or more in central thickness
Exclusion criteria
Epithelium-off accelerated corneal crosslinking is a procedure in which the cornea is soaked with riboflavin followed by exposure to ultraviolet irradiation in either pulsed-light or continuous-light modes to strengthen the corneal stroma and halt keratoconus progression.
Time frame: one year following surgery
Uncorrected and corrected distance visual acuity (UDVA & CDVA) using Snellen acuity chart
Time frame: one year following surgery
Manifest refraction spherical equivalent (MRSE) using Topcon autorefractometer
Time frame: one year following surgery
Scheimflug imaging device (Pentacam) for Diagnosis and follow up of Keratoconus after ACXL
Time frame: 3 months following surgery
Demarcation line depth is an outcome used to assess the success of CXL procedure using anterior segment ocular coherence tomography (AS-OCT)
Assiut University
Other
Pulsed Light Versus Continuous Light Accelerated Epithelium-Off Cross-linking for Treatment of Progressive Keratoconus; a Prospective Comparative Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT06818461
Corneal Diseases, Eye Diseases
Mohandessin, Giza Governorate, Egypt
View Trial DetailsNCT06100939
Corneal Diseases, Eye Diseases
Rowland Heights, California, United States
View Trial DetailsNCT06100952
Corneal Diseases, Eye Diseases
Scottsdale, Arizona, United States
View Trial DetailsNCT04418999
Allergy, Corneal Diseases
Chicago, Illinois, United States
View Trial Details