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IRCT20141019019581N5 IRCT 2023-09-04 Shiraz University of Medical Sciences To comparison effect of intracameral adrenalin solution with concentration 1/10000 & 1/100000 on corneal endothelium and macular thickness after uneventful phacoemulsification To comparison effect of intracameral adrenalin solution with concentration 1/10000 & 1/100000 on corneal endothelium and macular thickness after uneventful phacoemulsification 2011-09-23 anticipated 210 Complete https://irct.ir/trial/17498 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Study design and participants:In this prospective interventional study, we randomly enrolled 210 eligible patients with age-related cataracts, all of whom were scheduled for unilateral phacoemulsification and intraocular lens (IOL) implantation . All the cases underwent a complete ocular examination including Snellen VA, applanation tonometry, slit-lamp exam, and dilated fundus examination. Lens Opacities Classification System (LOCS) III protocol (Chylack et al. 1993) was used preoperatively for grading of nuclear and cortical cataracts to rule out preoperative differences between the two groups . The mean surgery time (min), mean US time, mean US power(%), mean total Us energy, and mean irrigation volume(mL) were measured during the surgery for all patients. Surgical Procedure:Before the surgery, tropicamide 1.0% was used to achieve mydriasis in all patients. All operations were performed by the same surgeon (S. B) and a similar phacoemulsification machine was used for all operations. A similar technique was used for all operations: Using general or local anesthesia, after preparation with Povidone Iodine 10%, a 3.0 mm temporal clear cornea incision was created. Then, the control group did not receive epinephrine; the epinephrine groups received either an injection of 0.2 mL preservative-free epinephrine (1:10000) or 0.2 mL preservative-free epinephrine (1:100000). In all the 3 groups, the same visoelastic (HPMC, Ocucoat, Bausch & Lomb) was injected into the anterior chamber. Then, a continuous curvilinear capsulorhexis was created and Phacoemulsification performed using a stop-and-chop technique. The cortex was aspirated in irrigation/aspiration mode. Sodium hyaluronate 1% (Healon) was injected into the capsular bag and a foldable acrylic IOL implanted in the bag. Viscoelastic was irrigated from the anterior chamber and stromal hydration was used to close the corneal incisions. Topical chloramphenicol and prednisolone acetate eyedrops were given 6 times daily for the first week. Then, Chloramphenicol eye drop was continued 4 times daily for 3 weeks and the prednisolone acetate was slowly tapered during 4 weeks postoperatively and then discontinued. Postoperative examinations included BSCVA, slit-lamp biomicroscopy, IOP measurement, and indirect ophthalmoscopy.Study Outcome Measures:Corneal endothelial density: Central corneal endothelial photographs were taken with the Topcon SP-3000P specular microscope (Topcon Europe BV, Capelle a ⁄ d Ijssel,the Netherlands) preoperatively and at 3 month postoperatively. The corneal endothelial morphology was calculated from a central cluster of 10 cells from each photograph. Three photographs were taken from the center and the measurements recorded and veraged. The hexagonality quantifying the percentage of endothelial cells with the ideal hexagonal cell shape was also calculated and recorded. The coefficient of variation in cell size (CV) was also calculated. A comparison between pre- and postoperative values was performed. Macular thickness: OCT measurements were performed preoperatively and at 1,and 3 months postoperation. Macular thickness measurements were performed using Optical coherence tomography (Spectralis OCT, Heidelberg Engineering, SN:TR-KT-1457, Germany). The central 1.0 mm retinal thickness measurements were taken from the fast macular thickness maps, which were calculated from the 6 low-resolution diagonal scans. The 6 radial diagonal scans were used to quantitatively evaluate the macula. Before the inclusion, all patients in the study had normal macular morphology and thickness, Randomization description: Randomization and assignment were performed using research randomizer software (version 4.0; Urbaniak, G. C. & Plous, S.; 2011), the patients were entered into three groups: intervention 1, intervention 2 and control group, Blinding description: Double blind technique patient and the person who measured endothelial cell count and macular thickness was blind to grougs. 3 Cataracts. Intervention 1: Patients who received epinephrine without preservative with a concentration of 1.1000. Intervention 2: Intervention group: Patients who received epinephrine without preservative with a concentration of 1.100000. Intervention 3: Control group: Patients received balanced salt serum (BSS) as placebo. Yes - There is a plan to make this available What will be shared: We have no plans at this time When: We have no plans at this time To whom: We have no plans at this time Conditions: We have no plans at this time Where to obtain: We have no plans at this time How to obtain: We have no plans at this time Comments:
public Doctor Shahram Bamdad
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 Shahrambamdad@yahoo.com Shiraz University of Medical Sciences scientific Doctor Shahram Bamdad
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134997446 +98 71 3230 5410 Shahrambamdad@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 210patients with cataract that refer to poostchi clinic no limit no limit Both Patients with a history of eye surgery Patients with a history of eye trauma Patients with a history of diabetes mellitus and high eye pressure Patients with a history of exfoliation syndrome Patients with a history of corneal edema Patients with a history of macular problems Patients with any complications during the operation, including long phaco time, iris trauma and capsule rupture H25.1 Age-related nuclear cataract Treatment - Surgery Treatment - Surgery Treatment - Surgery Patients who received epinephrine without preservative with a concentration of 1.1000 Intervention group: Patients who received epinephrine without preservative with a concentration of 1.100000. Control group: Patients received balanced salt serum (BSS) as placebo Changes in macular thickness in the intervention groups. Timepoint: Before the intervention and three months later. Method of measurement: by specular device. Corneal endothelium cell density. Timepoint: Before operation and 3 month after operation. Method of measurement: Specular microscope. The size of corneal endothelium cells. Timepoint: Before the operation and 3 months after the operation. Method of measurement: Specular microscope. The shape of corneal endothelium cells. Timepoint: Before the operation and 3 months after the operation. Method of measurement: Specular microscope. Shiraz University of Medical Sciences Approved 2013-10-27 Ethics committee of Shiraz University of Medical Sciences Zand Boulevard Shiraz Fars Iran (Islamic Republic of)