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IRCT20210901052357N2 IRCT 2022-05-23 Iran University of Medical Sciences Subconjunctival 5-fluorouracil on the outcome of Ahmed valve in neovascular glaucoma Evaluation of the effect of subconjunctival 5-fluorouracil on the outcome of Ahmed valve in neovascular glaucoma: Randomized Clinical Trial 2022-01-26 anticipated 70 Complete https://irct.ir/trial/60124 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, we will use the random block method so that the number of samples in the two groups is the same. The blocks are considered as 4, with a and b representing the two study groups. All possible permutations for a block of 4 are as follows: aabb, abba, abab, bbaa, baab, baba. From these 6 permutations, one block will be selected at a simple random time. The reason for this is to reduce the likelihood that final allocations will be predictable. After selecting the block, the person will be assigned to group a or b in the same way. N/A neovascular glaucoma. Intervention 1: Intervention group:Patients with neovascular glaucoma undergoing shunt implant surgery with during surgery. This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, Mitomycin C at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications. Intervention 2: Intervention group: Patients with neovascular glaucoma undergoing shunt implant surgery with 5FU during and after surgery .This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, Mitomycin C at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications. Also in the first, third and fifth weeks, 5FU injections are given as a subconjugate with a volume of 0.1 ml containing 5 mg of the drug. 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 Farhad Najafzadeh
Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 6999 Najafzadeh.Farhad@gmail.com Iran University of Medical Sciences scientific Arezoo Miraftabi
Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 6999 arezoomiraftabi@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients with neovascular glaucoma Lack of eye pressure control with medication 18 years no limit Both Patients with other types of glaucoma H40 Glaucoma Treatment - Surgery Treatment - Surgery Intervention group:Patients with neovascular glaucoma undergoing shunt implant surgery with during surgery. This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, Mitomycin C at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications. Intervention group: Patients with neovascular glaucoma undergoing shunt implant surgery with 5FU during and after surgery .This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, Mitomycin C at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications. Also in the first, third and fifth weeks, 5FU injections are given as a subconjugate with a volume of 0.1 ml containing 5 mg of the drug. Intraocular pressure (IOP). Timepoint: Before surgery, first day, first week, third week, fifth week, third month, sixth month after surgeryا. Method of measurement: Intraocular pressure is measured with a Goldmann Applanation Tonometer (GAT). Iran University of Medical Sciences Approved 2022-01-25 Ethics committee of Iran University of Medical Sciences Rasoul Akram Hospital, Maziar Mansouri St., Sattar Khan St. Tehran Tehran Iran (Islamic Republic of)