The aim of this study is to compare Mydrane ®, mydriatic eye drops and Mydriasert ® in terms of pupil site stability, surgical time, visual field and anterior chamber configuration modifications among primary open angle glaucoma (POAG) patients during cataract extraction surgery.
60 patients with coexisting POAG and cataract who underwent elective cataract extraction. All patients underwent ophthalmic routine examinations including automatic visual field examination, anterior chamber configuration, specular microscopy and arterial blood pressure measurement prior to surgery, 24 hours and 30 days postoperatively. All cataract surgeries were videorecorded, and all measurements were performed using media player. 20 patients received topical mydriatic eye drops, 20 patients received Mydriasert ® whereas 20 patients received intracameral injection of Mydrane ® just after the first incision.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
60 patients with coexisting POAG and cataract who underwent elective cataract extraction. All patients underwent ophthalmic routine examinations including automatic visual field examination, anterior chamber configuration, specular microscopy and arterial blood pressure measurement prior to surgery, 24 hours and 30 days postoperatively. All cataract surgeries were videorecorded, and all measurements were performed using media player. 20 patients received topical mydriatic eye drops, 20 patients received Mydriasert ® whereas 20 patients received intracameral injection of Mydrane ® just after the first incision.
Policlinico Gemelli
Roma, Italy
Stability of mydriasis
All cataract surgeries were video-recorded, and all measurements were performed using media player software (VideoLAN Non-Profit Organization, Paris, France) with two different operators (M.R. and F.R.) based on the images acquired immediately prior to the corneal incision (T1), injection of the ophthalmic viscosurgical device (OVD) (T2), capsulorhexis (T3), IOL insertion (T4), and cefuroxime injection (end of surgery) (T5). The pupil size immediately prior to the capsulorhexis was defined as the maximum mydriasis. We recorded all the surgery with OPMI LUMERA® 700 ZEISS and then measured with media player software all the pupil size.
Time frame: 1 hour
Duration of surgery
mean duration of surgery, All cataract surgeries were video-recorded, and all measurements were performed using media player software (VideoLAN Non-Profit Organization, Paris, France) with two different operators (M.R. and F.R.) based on the images acquired immediately prior to the corneal incision (T1), injection of the ophthalmic viscosurgical device (OVD) (T2), capsulorhexis (T3), IOL insertion (T4), and cefuroxime injection (end of surgery) (T5).
Time frame: 1 hour
Pain experience
Patients were asked to complete a questionnaire using the the Visual Analogue Scale (VAS) scale to evaluate surgical pain related to the procedure. The scale simply consists of a 10 cm strip of paper which has two "end points" at the ends which are defined as "no pain" and "the worst pain I can imagine".
Time frame: up to 4 weeks
Central corneal thickness (CCT) and corneal endothelium cell density (CD) changes
Specular microscopy values were evaluated by using the Perseus (CSO, Italy) The Perseus specular microscope is a non-contact automated instrument with auto alignment and a touch screen that automatically conducts studies for measuring endothelial cell layer density using the corner method to analyze the endothelial cells. The instrument has a reliability index that evaluates the quality of acquisition, this is based on a calculation of the percentage of the total endothelium area relative to the maximum number of countable endothelial cells per field (edited area). Corneal endothelial cell density (CD) is calculable using a units of measure based on cells/mm2.
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Time frame: up to 4 weeks
Visual field defects
The 30-2 SITA STANDARD algorithm (HFAII740: Humphrey Field Analyzer II; Carl Zeiss Meditec, Dublin, California, USA) was used for the standard automatic visual field examination of all the patients to investigate the visual field defects, mean deviation (MD), and pattern standard deviation (PSD) modifications at baseline and 30 days postoperatively. Visual field testing was performed with visual correction in a dark room.
Time frame: up to 4 weeks
Anterior segment parameters variations
Anterior chamber depth (ACD) and both nasal and temporal iridocorneal angles were measured by a single experienced operator who obtained a horizontal scan, including sections of the nasal and temporal quadrants of all the patients, using AS-OCT (Visante, software version 2.01.88; Carl Zeiss Meditec, Dublin, CA) in a dark room with the images centered on the pupil . High-resolution images were taken in the anterior segment single-scan mode along the horizontal meridian with the subjects seated.When the corneal reflex was visible, the image was captured. ACD (from the corneal endothelium to the anterior surface of the crystalline lens) were then measured (ACD was obtained using the on-screen calibrated caliper function).
Time frame: up to 4 weeks