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IRCT20240121060751N1 IRCT 2024-02-02 Ahvaz University of Medical Sciences Comparison of the effect of combined surgery of inferior oblique muscle myectomy and superior rectus muscle recession with combined surgery of muscle myectomy and inferior oblique muscle myectomy combined with z-tenotomy of superior rectus muscle by microsurgery method (MICS) Investigating the effect of inferior oblique muscle mycotomy along with superior rectus muscle reses with inferior oblique muscle mycotomy combined with upper rectus z-tenotomy by microsurgery (MICS) method on the amount of vertical deviation in patients with inferior oblique muscle hypertrophy more than 8-10 prism diopters : clinical trial 2024-02-07 anticipated 60 Complete https://irct.ir/trial/75069 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be divided into two groups using the random permutation method. The method of assigning the intervention to patients is randomly and by the method of randomized permutation blocks with random block sizes of 4, 6 and 8 (using the table related to random permutations). The randomization list is prepared by a statistician. The intervention used in this research is allocated according to a randomized list. 3 Mycotomy surgery of the inferior oblique muscle. Intervention 1: Intervention group: The first group is lower oblique muscle myectomy and upper rectus muscle recession. Intervention 2: For the second group, the combined surgery of inferior oblique muscle mycotomy with minimally invasive spinal surgery (MIS) of the superior rectus muscle is performed minimally. 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 I haven't decided yet, the release schedule is not clear yet
public Gholamreza Khataminia
24 metery street, east sahely highway, ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 111 0870 khataminia@Hotmail.com Ahvaz University of Medical Sciences scientific Gholamreza Khataminia
24 metery street, east sahely highway, ahvaz
Ahvaz Iran (Islamic Republic of) 6193673166 +98 916 111 0870 khataminia@Hotmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) All patients with primary and secondary inferior oblique muscle hypertrophy whose primary position deviation is above 10 prism diopters. no limit no limit Both People who had neurological and muscular diseases, patients who underwent eye surgery in the past, and also people who do not follow up regularly, will be excluded from the study. H51.8 Other specified disorders of binocular movement Treatment - Surgery Treatment - Surgery Intervention group: The first group is lower oblique muscle myectomy and upper rectus muscle recession For the second group, the combined surgery of inferior oblique muscle mycotomy with minimally invasive spinal surgery (MIS) of the superior rectus muscle is performed minimally. Degree of vertical deviation in patients. Timepoint: After the operation, it will be the first, third and seventh day and the third and sixth month. Orthopedic examinations applied before surgery will be repeated in the follow-ups and the results will be recorded. All patients will be operated by one surgeon. Method of measurement: If there is, the amount of deviation through the prism cover test. Visual acuity. Timepoint: After the operation, it will be the first, third and seventh day and the third and sixth month. Orthopedic examinations applied before surgery will be repeated in the follow-ups and the results will be recorded. All patients will be operated by one surgeon. Method of measurement: Using Snellen's chart and on pre-school age patients, cooperation level will be measured by finger counting method. Ahvaz University of Medical Sciences Approved 2024-01-13 Research Ethics Committee of Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical SciencesŲŒ Koi GolestanŲŒ Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)