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IRCT20200502047271N1 IRCT 2022-09-20 Esfahan University of Medical Sciences " Review of Long term Outcome of Intermittent Exotropia Surgery with General Anesthesia in Adults"؛"Review of Long term Outcome of Intermittent Exotropia Surgery with sedation and Local Anesthesia with Adjustment during surgery in Adults " Review and Comparison of Long-term Outcome of Intermittent Exotropia Surgery in Adults in Two Different Group with General Anesthesia and sedation with Local Anesthesia with Adjustment during surgery 2022-08-23 anticipated 50 Complete https://irct.ir/trial/47715 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Block Randomization: A table with four columns and rows is prepared according to the number of patients, then people are placed in the houses of the table based on the toss of a coin, for this purpose, the Heads is assigned to the case group and the Tails is assigned to the control group. For example, if the coin toss is Heads-Tails, Heads-Tails, the four columns of the table are placed as case- control, case- control, and if the coin toss is Heads-Heads for the two patients, then for the next two patients There is no coin toss and they are placed in the control group and thus the number of samples is divided equally between the two groups, Blinding description: Patients are not aware of their allocation to the study groups, but were randomly assigned to one of the two study groups by the researcher. The operation of all patients is known to the surgeon and only the type of anesthesia differs based on randomization. N/A Intermittent exotropia. Intervention 1: First Intervention group: underwent definite muscle surgery including bilateral lateral rectus recession (BLRc) under GA.GA was induced by administering a combination of propofol, succinylcholine,and sevoflurane.BLRc , a limbal approach was taken to create a triangular conjunctival flap that extended toward the lateral rectus (LR) muscle. The LR was delineated and caught by a muscle hook and secured by two 6-0 Vicryl sutures on the upper and lower borders of muscle tendon. A caliper was further used to mark the new insertion site, which was established on to the sclera. Intervention 2: Second Intervention group: underwent the same muscle surgeries under local anesthesia and IV sedation.Tetracaine 1% was used for topical anesthesia . On the other hand, IV sedation was induced by administering acombination of IV benzodiazepines, propofol, and ketamine, where necessary. 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 further information
public Abolfazl Karimi harandi
Quods Square, Modarres Street, Isfahan, Iran;
Esfahan Iran (Islamic Republic of) 8149644875 +98 31 3445 2032 akarimiharandi@yahoo.com Esfahan University of Medical Sciences scientific Abolfazl Karimi harandi
Quods Square, Modarres Street, Isfahan, Iran
Esfahan Iran (Islamic Republic of) 8149644875 +98 31 3445 2032 akarimiharandi@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Basic intermittent exotropia below 60 prism diopters 18 years no limit Both Neurological dificit vertical muscle dysfunction Patients with amblyopia decreased visual acuity of any cause history of strabismus or any other ocular surgery Abnormal ophthalmologic exam H50.34 Intermittent alternating exotropia Treatment - Surgery Treatment - Surgery First Intervention group: underwent definite muscle surgery including bilateral lateral rectus recession (BLRc) under GA.GA was induced by administering a combination of propofol, succinylcholine,and sevoflurane.BLRc , a limbal approach was taken to create a triangular conjunctival flap that extended toward the lateral rectus (LR) muscle. The LR was delineated and caught by a muscle hook and secured by two 6-0 Vicryl sutures on the upper and lower borders of muscle tendon. A caliper was further used to mark the new insertion site, which was established on to the sclera. Second Intervention group: underwent the same muscle surgeries under local anesthesia and IV sedation.Tetracaine 1% was used for topical anesthesia . On the other hand, IV sedation was induced by administering acombination of IV benzodiazepines, propofol, and ketamine, where necessary Angle of Deviation : Quantitative amount of exotropia based on prism measurement with prism diopter (PD). Timepoint: Before surgery and one week and six months after surgery. Method of measurement: prism cover test. Esfahan University of Medical Sciences Approved 2020-05-11 Ethics committee of Isfahan University of Medical Sciences Alley 40, 3rd dead end, Modarres St, Ghods Sq Esfahan Isfehan Iran (Islamic Republic of)