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NCT07203976
Visual and Refractive Outcomes Following Stream Light Photorefractive Keratectomy (55μm Epithelial Removal) Versus Conventional Photorefractive Keratectomy
Conditions: Photorefractive Keratectomy
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: No
Enrollment: 100
Sponsor: Assiut University
Location: Faculty of medicine, Assiut Asyut
Summary
Photorefractive keratectomy (PRK) is a well-established corneal refractive surgery that involves epithelial removal followed by stromal ablation to correct myopia, hyperopia, and astigmatism. The method of epithelial removal in PRK significantly impacts healing, pain levels, and visual outcomes.
Trans-epithelial PRK (StreamLight) performed on the EX500 excimer laser platform removes the epithelium and reshapes the corneal stroma in a single laser-guided step, potentially reducing tissue manipulation and enhancing epithelial healing. In contrast, manual epithelial removal PRK involves mechanical debridement, with epithelial removal depth being manually controlled. The variability of epithelial thickness in StreamLight PRK may influence visual outcomes, whereas in manual PRK, a fixed epithelial removal depth of 55 microns provides a standardized approach.
Eligibility Criteria
Inclusion Criteria:
* Patients aged 18-40 years.
* Myopia up to -6.00 D and astigmatism up to -3.00 D.
* Stable refraction for at least one year.
* No history of ocular surgery or corneal pathology.
Exclusion Criteria:
* Presence of keratoconus or suspected corneal ectasia.
* Severe dry eye disease or significant ocular surface disease.
* History of autoimmune disease or systemic conditions affecting wound healing.
* Prior herpetic eye disease.
Source: ClinicalTrials.gov (NCT07203976). StuddyBuddy aggregates publicly available trial information.