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IRCT20220120053771N1 IRCT 2022-02-08 Tehran University of Medical Sciences Success rate in the treatment of congenital nasolacrimal duct obstruction Comparing the modified surgical interventions with Probing, Turbinate fracture and Crowforded in treatment of congenital obstruction of nasolacrimal duct: a Randomized controlled clinical trial 2022-03-21 anticipated 164 Complete https://irct.ir/trial/61428 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After determining the patients with the ability to enter the study, a three-digit code will be assigned to each patient, which will introduce the patient in all stages of the study and replace his name and other identity details. Then, a data collection form will be completed for patients and written informed consent will be obtained. In the next stage, patients will be divided into one of 4 intervention groups based on the principles of randomization and blinding and using block randomization method. Patients and evaluators will be unaware of the type of intervention performed during the study and the principles of dual blindness will be observed. Randomization will be based on a predetermined list. May 164 patients will be divided into 4 groups based on sex blocks. The desired list will be prepared by Randlist software, Blinding description: After determining the patients with the ability to enter the study, a three-digit code will be assigned to each patient, which will introduce the patient in all stages of the study and replace his name and other identity details. Patients and evaluators will be unaware of the type of intervention performed during the study and the principles of dual blindness will be observed. N/A Congenital obstruction of the nasolacrimal duct. Intervention 1: Intervention group: Nasolacrimal duct probing surgery with rupture of the lower nasal turbine. Intervention 2: Intervention group: Nasolacrimal duct probing surgery with Crawford implantation. Intervention 3: Intervention group: Nasolacrimal duct probing surgery as a basic procedure. Intervention 4: Intervention group: Nasolacrimal duct probing surgery with lower nasal turbine fracture and Crawford implantation as the gold standard method. 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 more information
public Sahel Soltani Shahgoli
Farabi hospital, South Kargar Ave, Qazvin Sqr
Tehran Iran (Islamic Republic of) 1336616351 +98 21 5540 0003 sahelsoltan93@gmail.com Tehran University of Medical Sciences scientific Sahel Soltani Shahgoli
Farabi hospital, South Kargar Ave, Qazvin Sqr
Tehran Iran (Islamic Republic of) 1336616351 +98 21 5540 0003 sahelsoltan93@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) pure type of congenital nasolacrimal duct obstruction, Age under 5 years, negative fluorosin test without underlying disease or other syndromic disorder, without previous history of nasolacrimal duct intervention or manipulation. no limit 5 years Both Patient / parent dissatisfaction with the study, uncontrollable infection, underlying disease or limitation of anesthesia, concomitant tumors or bleeding disorders, concomitant disorders of facial ossification, cleft palate (even (Secretly), developmental disorders or defects, problems related to the pituitary gland or Ratke sinus and other abnormalities of the midline of the face. H04.53 Neonatal obstruction of nasolacrimal duct Treatment - Surgery Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group: Nasolacrimal duct probing surgery with rupture of the lower nasal turbine Intervention group: Nasolacrimal duct probing surgery with Crawford implantation Intervention group: Nasolacrimal duct probing surgery as a basic procedure Intervention group: Nasolacrimal duct probing surgery with lower nasal turbine fracture and Crawford implantation as the gold standard method Comparison of success rate in modified surgical intervention methods with probing method with turbine fracture and Crawford implantation in the treatment of congenital nasolacrimal duct obstruction. Timepoint: patients will be examined for the success of the intervention as well as the complications of the interventionm, a day after the intervention,. At 3 months and 6 months after the surgery, patients will be re-evaluated for the visual system and fluorocin test will be performed, and the results of follow-up and examination at times 0, 3 and 6 (months) will be evaluated and compared. Method of measurement: At each follow-up, patients will undergo a complete evaluation of the visual system and perform a fluorescein test. Tehran University of Medical Sciences Approved 2022-03-01 Ethics committee of Tehran University of Medical Sciences Tehran university of medical sciences, Pour sina Ave, keshavarz Blv, Tehran Tehran Tehran Iran (Islamic Republic of)