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IRCT20170325033136N2 IRCT 2018-05-18 Alexandra Preda Micropulse Transcleral Cyclophotocoagulation in the treatment of refractary glaucoma mTSCPC Micropulse Transcleral Cyclophotocoagulation in the treatment of refractary glaucoma 2637-09-11 anticipated 100 Pending https://irct.ir/trial/25638 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment. N/A Glaucoma, IOP. Intervention group: the intervention group is consisted of the nontreated eye. In each patient only one eye is treated with micropulse cyclophotocoagulation, the fellow eye represents control group. The treated group, consisted of the treated eye, underwent one session of micropulse transcleral cyclophotocoagulation(mTSCPC), after which standard eye drops were prescribed for 2 weeks. The treatment consisted of ciclopentolate, cortison (fluorometolona) and antibiotic (netilmicina). The glaucoma treatment was never interupted. The protocol included retrobulbar anesthesia with 1:1 mixture of 0.75% bupivacaine and 4% lidocaine and intravenous sedation (fentanyl/propofol), according to the patients’ pain tolerance. Laser settings were 2000 mW of 810 nm infrared diode laser set on micropulse delivery mode. The laser was delivered over 360° for 160-260 ms. The duty cycle was 31.3 %, which translated to 0.5 ms of “on time” and 1.1 ms of “off time”. The probe was applied in a sweeping motion, keeping firm pressure and moved from 10 o’clock to 2 o’clock for the superior quadrant, and from 4 o’clock to 8 o’clock for the inferior quadrant. The 3 and 9 o’clock areas and also any area of thinned sclera were avoided. Examinations were performed at 1 week, 1 month, 3 months, 6 months and 12 months after the procedure, and included anterior segment examination, anterior chamber reaction, and Goldmann applanation tonometry. All the ocular determinations were made between 9 and 11 am. We monitored intraocular pressure, best corrected visual acuity (BCVA), number and type of medications used. The device is called MicroPulse® P3 Glaucoma Device (MP3) IRIDEX. we want to comapre the intraocular pressure of the treated eye before the mTSCPC and how much it dropped, after one year. We also compare with the nontreated eye, and if the laser had any influence on the nontreated eye, considering the sympathetic connection between the eyes. The treated group consists 100 eyes, and the nontreated gropus, 100 eyes, the fellow eye.. No - There is not a plan to make this available Justification or reason for not sharing IPD is This are confidential and personal information
public Alexandra Preda
Bulevardul 3 August, nr 2
Timisoara Romania 300668 +40 745 113 511 alexandrapreda004@gmail.com Centrul Oftalmologic Prof Dr Munteanu scientific Alexandra Preda
B dul 3 August nr 2
Timisoara Romania 300668 +40 745 113 511 superstarale@yahoo.com Clinica Prof Dr Munteanu Romania Intraocular pressure higher than 21 mmhg Age > 18 Signed informed consent 18 years no limit Both Uveitis Ocular surgery in the last 3 months, prior to study enrolment. H40.9 Unspecified glaucoma Treatment - Devices Intervention group: the intervention group is consisted of the nontreated eye. In each patient only one eye is treated with micropulse cyclophotocoagulation, the fellow eye represents control group. The treated group, consisted of the treated eye, underwent one session of micropulse transcleral cyclophotocoagulation(mTSCPC), after which standard eye drops were prescribed for 2 weeks. The treatment consisted of ciclopentolate, cortison (fluorometolona) and antibiotic (netilmicina). The glaucoma treatment was never interupted. The protocol included retrobulbar anesthesia with 1:1 mixture of 0.75% bupivacaine and 4% lidocaine and intravenous sedation (fentanyl/propofol), according to the patients’ pain tolerance. Laser settings were 2000 mW of 810 nm infrared diode laser set on micropulse delivery mode. The laser was delivered over 360° for 160-260 ms. The duty cycle was 31.3 %, which translated to 0.5 ms of “on time” and 1.1 ms of “off time”. The probe was applied in a sweeping motion, keeping firm pressure and moved from 10 o’clock to 2 o’clock for the superior quadrant, and from 4 o’clock to 8 o’clock for the inferior quadrant. The 3 and 9 o’clock areas and also any area of thinned sclera were avoided. Examinations were performed at 1 week, 1 month, 3 months, 6 months and 12 months after the procedure, and included anterior segment examination, anterior chamber reaction, and Goldmann applanation tonometry. All the ocular determinations were made between 9 and 11 am. We monitored intraocular pressure, best corrected visual acuity (BCVA), number and type of medications used. The device is called MicroPulse® P3 Glaucoma Device (MP3) IRIDEX. we want to comapre the intraocular pressure of the treated eye before the mTSCPC and how much it dropped, after one year. We also compare with the nontreated eye, and if the laser had any influence on the nontreated eye, considering the sympathetic connection between the eyes. The treated group consists 100 eyes, and the nontreated gropus, 100 eyes, the fellow eye. IOP decrease. Timepoint: 1 week, 1 month, 3 months,6 months, 1 year. Method of measurement: Goldman aplanotonometry. Pain endurance. Timepoint: 5 minutes after procedure. Method of measurement: VAS scale. Number of eye drops after the procedure to control the IOP. Timepoint: 1 month, 6 months, 1 year. Method of measurement: Asking patient. Alexandra Preda Approved 2637-09-06 The ethics committee of the Ophtalmologica B dul 3 August nr 2, Timisoara Timisoara Timis Romania