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IRCT20230330057786N1 IRCT 2023-09-05 Zahedan University of Medical Sciences Comparison of the effect of laser and medicine in glaucoma SLT Comparison of the effect of antiglaucoma drugs with Selective Laser Trabeculoplasty (SLT) in patients with primary open angle glaucoma 2023-09-23 anticipated 60 Complete https://irct.ir/trial/71735 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of random allocation will be using the block method and the use of random blocks. Blocks of four will be used for each intervention group. In this way, a person other than the doctor evaluating the outcome determines the treatment block with the help of random numbers obtained from the computer. Blocks of four will include: TCCT, TCTC, TTCC, CCTT, CTCT, CTTC. N/A Primary open angle glaucoma. Intervention 1: Intervention group 1: The first intervention group: Selective Laser Trabeculoplasty group: a few minutes before the start of Selective Laser Trabeculoplasty, tetracaine drops of 0.5% are poured into the target eye. During the study, all patients in the SLT group underwent laser treatment (Elex SOLO-SLT 2011). It is a Nd:YAG (Q-switched) laser that emits 532 nm radiation with a pulse duration of 3 nanoseconds and a spot size of 400 micrometers and a pulse energy in the range of 0.2 to 1.7 mJ. With the patient sitting and the head placed in the slit lamp device, a goniolens (SLT-Retinal BD10052) is placed on the patient's eye. After that, the laser will be focused on the trabecular meshwork. The entire width of the trabecular mesh with a spot size of 400 µm is irradiated with each pulse. The laser energy will be initially set to 0.8 mJ and a laser pulse will be emitted at the 12 o'clock position. If the whitening of the trabecular meshwork does not occur or the cavitation bubble does not appear, the pulse energy will be increased by increasing 0.1 mJ until the formation of the bubble. Laser therapy is performed in 360 degrees. Intervention 2: Intervention group 2: Drug therapy group: In the drug therapy group, based on the guidelines provided in the ophthalmology reference books, the first step is to start the treatment with an ophthalmic prostaglandin analog such as latanoprost eye drops (containing 0.005% latanoprost - Sina darou Company). The second step, if the treatment goal is not met during the one-month follow-up, adding a beta-blocker such as timolol eye drops (containing 0.5% timolol maleate - Sina darou Co. with the brand name Optimol) or betaxolol eye drops (containing 0.5% betaxolol hydrochloride - Co. Sina darou will be under the brand name Betaxol). The third step will be brimonidine eye drops (containing 0.2% brimonidine tartrate - Sina darou company under the brand name Brimogan) and the fourth step will be adding dorzolamide eye drops (containing 2% dorzolamide hydrochloride - Sina darou company). Patients will be included in the study who have been newly diagnosed or who have not reached the target IOP determined by the doctor despite regular use of the standard medicine for the first line (latanoprost eye drops). The importance of how to take medicines is explained to the patients, and the patients are asked to record the side effects of the medicines, such as eye redness, tears, itchy eyes, dry eyes, etc. Patients are advised not to discontinue the drug in case of mild to moderate side effects such as mild redness or itchy eyes. In case of severe side effects such as headache, confusion or worsening of eye pain, contact the treating physician (if the treating physician confirms that the complication is caused by the use of the mentioned drug and continuing to use it for the overall health of the body and health The patient's eye is not suitable, the person is excluded from the study). 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 Mohammad Arish
Shahid Motahari Blvd
Zahedan Iran (Islamic Republic of) کد پستی ندارد... +98 54 3322 4991 Arish.Mohammad@gmail.com Zahedan University of Medical Sciences scientific Mohammad Arish
Shahid Motahari Blvd
Zahedan Iran (Islamic Republic of) کد پستی ندارد... +98 54 3322 4991 Arish.Mohammad@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Age more than 18 years Diagnosis of POAG (POAG is an optic neuropathy with increased intraocular pressure in which the angle of the anterior chamber of the eye is open and no secondary disease or cause can be found to justify optic nerve damage or increased intraocular pressure). Newly diagnosed patients and those who are currently receiving the standard first-line treatment, i.e. latanoprost eye drops, but their target IOP has not been achieved. 18 years no limit Both Secondary glaucoma diagnosis One eye patients (patients whose other eye is blind for any reason). Having very high IOP (above 30 mm Hg) Patients who have currently received the maximum tolerated medical treatment (Maximum Tolerated Medical Treatment), but despite the treatment, their IOP has not been controlled. History of laser trabeculoplasty or retina surgery History of cataract surgery in the last 3 months Active eye infection or inflammation Narrow eye angle Pregnant or lactating women Any eye disease that prevents accurate IOP measurement. Like a corneal scar Any unstable medical condition that prevents compliance with the scientific and ethical bases of the study protocol. H40.1 Open-angle glaucoma Treatment - Other Treatment - Drugs Intervention group 1: The first intervention group: Selective Laser Trabeculoplasty group: a few minutes before the start of Selective Laser Trabeculoplasty, tetracaine drops of 0.5% are poured into the target eye. During the study, all patients in the SLT group underwent laser treatment (Elex SOLO-SLT 2011). It is a Nd:YAG (Q-switched) laser that emits 532 nm radiation with a pulse duration of 3 nanoseconds and a spot size of 400 micrometers and a pulse energy in the range of 0.2 to 1.7 mJ. With the patient sitting and the head placed in the slit lamp device, a goniolens (SLT-Retinal BD10052) is placed on the patient's eye. After that, the laser will be focused on the trabecular meshwork. The entire width of the trabecular mesh with a spot size of 400 µm is irradiated with each pulse. The laser energy will be initially set to 0.8 mJ and a laser pulse will be emitted at the 12 o'clock position. If the whitening of the trabecular meshwork does not occur or the cavitation bubble does not appear, the pulse energy will be increased by increasing 0.1 mJ until the formation of the bubble. Laser therapy is performed in 360 degrees. Intervention group 2: Drug therapy group: In the drug therapy group, based on the guidelines provided in the ophthalmology reference books, the first step is to start the treatment with an ophthalmic prostaglandin analog such as latanoprost eye drops (containing 0.005% latanoprost - Sina darou Company). The second step, if the treatment goal is not met during the one-month follow-up, adding a beta-blocker such as timolol eye drops (containing 0.5% timolol maleate - Sina darou Co. with the brand name Optimol) or betaxolol eye drops (containing 0.5% betaxolol hydrochloride - Co. Sina darou will be under the brand name Betaxol). The third step will be brimonidine eye drops (containing 0.2% brimonidine tartrate - Sina darou company under the brand name Brimogan) and the fourth step will be adding dorzolamide eye drops (containing 2% dorzolamide hydrochloride - Sina darou company). Patients will be included in the study who have been newly diagnosed or who have not reached the target IOP determined by the doctor despite regular use of the standard medicine for the first line (latanoprost eye drops). The importance of how to take medicines is explained to the patients, and the patients are asked to record the side effects of the medicines, such as eye redness, tears, itchy eyes, dry eyes, etc. Patients are advised not to discontinue the drug in case of mild to moderate side effects such as mild redness or itchy eyes. In case of severe side effects such as headache, confusion or worsening of eye pain, contact the treating physician (if the treating physician confirms that the complication is caused by the use of the mentioned drug and continuing to use it for the overall health of the body and health The patient's eye is not suitable, the person is excluded from the study). Percentage of eye pressure reduction in glaucoma patients. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 6 months after the start of the treatment. Method of measurement: Goldman tonometer. Visual acuity. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 6 months after the start of the treatment. Method of measurement: Snellen vision measurement chart. Zahedan University of Medical Sciences Approved 2023-02-01 Ethics committee of Zahedan University of Medical Sciences No. 7, Rajaei st 4, Shahid Rajaei Blvd., Zahedan city Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)