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IRCT20230124057199N1 IRCT 2023-08-05 Mashhad University of Medical Sciences Comparison of moderate to high myopic astigmatism correction using PRK and transepithelial PRK Comparison of moderate to high myopic astigmatism correction using PRK and transepithelial PRK 2023-05-30 anticipated 35 Complete https://irct.ir/trial/68254 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization A lottery method is used for randomization. In this way, two completely folded papers are placed in a container (in such a way that the contents of the paper are not visible from the outside). The left eye is written on one paper and the right eye is written on the other paper. In another container, two folded papers are placed. PRK is written on one paper and trans PRK is written on the other paper for the patient who has written informed consent to participate. He signs the study, after mixing, he takes a piece of paper from each container, according to the contents of the paper, surgery will be performed, Blinding description: The patient is not told which eye is prk and which is trans A researcher who sees the patient in the follow-ups and examines various items in each eye does not know which eye is prk and which eye is trans. N/A moderate to high myopic astigmatism. Intervention 1: Intervention group: PRK PRK is an eye surgery that improves vision by correcting refractive errors such as astigmatism, nearsightedness, and farsightedness.In PRK surgery, the surgeon removes a very thin layer of the corneal tissue, the epithelium, to access the underlying tissue. The surgeon does this manually using an alcohol solution and a fine surgical knife. The next stage in the PRK operation, the surgeon uses a laser to correct the surface of the cornea at certain pre-planned points. The epithelial tissue that was initially removed will repair itself over the next few days. Intervention 2: Intervention group: TRANS PRK In the Trans-PRK method, or the No-Touch method, the surface layer (corneal epithelium) is removed with a laser instead of using tools and manually. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no information
public Siamak Zarei Ghanavati
Ferdowsi
Mashhad Iran (Islamic Republic of) 91885585858 0098513650256 zareis@mums.ac.ir Mashhad University of Medical Sciences scientific Siamak Zarei Ghanavati
Ferdowsi
Mashhad Iran (Islamic Republic of) 91885585858 0098513650256 zareis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) The patient has informed consent to participate in the study Patients with myopia between -2 and -6 Patients with astigmatism of 2 diopters and more no limit no limit Both Treatment - Surgery Treatment - Surgery Intervention group: PRK PRK is an eye surgery that improves vision by correcting refractive errors such as astigmatism, nearsightedness, and farsightedness.In PRK surgery, the surgeon removes a very thin layer of the corneal tissue, the epithelium, to access the underlying tissue. The surgeon does this manually using an alcohol solution and a fine surgical knife. The next stage in the PRK operation, the surgeon uses a laser to correct the surface of the cornea at certain pre-planned points. The epithelial tissue that was initially removed will repair itself over the next few days Intervention group: TRANS PRK In the Trans-PRK method, or the No-Touch method, the surface layer (corneal epithelium) is removed with a laser instead of using tools and manually. UCVA ( uncorrected visual acuity ). Timepoint: The end of the first, third and sixth months. Method of measurement: snellen chart. BCVA (best corrected visual acuity ). Timepoint: The end of the first, third and sixth months. Method of measurement: snellen chart. Comparison of high order aberration changes. Timepoint: The end of the first, third and sixth months. Method of measurement: aberrometry. Changes in the epithelial map. Timepoint: The end of the first, third and sixth months. Method of measurement: corneal oct with casia ii. Astigmatism correction. Timepoint: The end of the first, third and sixth months. Method of measurement: Auto refractometer. Mashhad University of Medical Sciences Approved 2022-11-19 ethics committee of Mashhad university of medical Sciences Khatam hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)