TIBA eye center
Asyut, 71516, Egypt
NCT Number: NCT05261685
Hyperopia is one of the commonest refractive errors encountered in ophthalmology practice.
Laser in situ keratomileusis (LASIK) has been widely used to correct hyperopia especially with the advent of femtosecond laser technology allowing larger flap creation suitable for peripheral hyperopic ablations with resultant predictable, effective, and safe refractive outcomes. However, the encountered LASIK flap complications encouraged many surgeons to assess efficiency and safety of surface ablation techniques such as photorefractive keratectomy (PRK) to correct hyperopia.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Asyut, 71516, Egypt
Although the initial refractive results of conventional manual or alcohol assisted PRK for hyperopia were encouraging, the frequently encountered post-PRK complications including undercorrection, overcorrection and regression of the hyperopic error had downgraded the conventional PRK as a preferred procedure for hyperopic correction.
Transepithelial PRK provides an alternative technique to uniformly remove the epithelium using the excimer laser to minimize the potential complications caused by mechanical or alcohol assisted epithelial removal in conventional PRK. Advances in transepithelial PRK technology have allowed refractive surgeons to remove the epithelium followed by stromal laser ablation in a single step instead of performing the procedure in 2 separate steps known as phototherapeutic keratectomy-photorefractive keratectomy (PTK-PRK).
Most of the previous studies paid particular attention to investigate the accuracy and safety of single-step transepithelial PRK in correcting myopia and myopic astigmatism. The aim of the current study is to evaluate the visual and refractive outcomes of the single-step transepithelial PRK procedure in correcting moderate hyperopia and hyperopic astigmatism.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single-step transepithelial Photorefractive keratectomy (PRK) is a corneal refractive surgical procedure utilized to correct myopia, hyperopia and astigmatism where excimer laser is used in a single step to remove the corneal epithelium followed by stromal laser ablation to correct the patient's refractive error.
Time frame: 12 months
Uncorrected and corrected distance visual acuity (UDVA,CDVA) measurement using logMAR distant charts.
Time frame: 12 months
Cycloplegic sphere, cylinder and refractive spherical equivalent (SEQ) were measured with auto-keratorefractometer (KR-8900:Topcon, Korea republic)
Time frame: 12 months
Postoperative keratorefractive changes in mean keratometry (Km) and Q value were recorded using pentacam (Oculus GmbH, Germany)
Time frame: 12 months
Post-PRK haze was evaluated using slit lamp based on Fantes et al. scale:
Grade 0: No haze, completely clear cornea
Grade 0.5: Trace haze seen with careful oblique illumination
Grade 1: Haze not interfering with the visibility of fine details of the iris
Grade 2: Mild obstruction of iris details
Grade 3: Moderate obstruction of the iris and lens
Grade 4: Complete opacification of the stroma in the area of the scar, anterior chamber is totally obscured.
Assiut University
Other
Twelve-Month Outcome of Single-step Transepithelial Photorefractive Keratectomy for Moderate Hyperopia and Hyperopic Astigmatism
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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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