Efficacy of the Intracamerally Administered Mydriatics for Cataract Surgery in Patients With Primary Open-angle Glaucoma.
Overview
- Phase
- Not Applicable
- Intervention
- Efficacy of a Standardized Intracameral Combination of Mydriatics and Anesthetic (Mydrane ®) for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma
- Conditions
- Cataract Surgery
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Stability of mydriasis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Ricci Francesco
Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility Criteria
Inclusion Criteria
- •patients \>18 years of age
- •diagnosed with age-related cataract with concomitant POAG well controlled by pharmacological therapy (IOP within its target during the entire day in a minimum of 12-month follow-up with constant use of anti-glaucoma medications)
- •required cataract extraction under local anesthesia
- •no history of previous surgery in the study eye
Exclusion Criteria
- •patients with POAG requiring glaucoma surgery
- •ocular trauma or infection
- •other forms of glaucoma
- •pseudo-exfoliation and exfoliation syndrome
Arms & Interventions
Group 1: Mydriatic Eyedrops
Group 1 patients included instillation of one drop each of tropicamide 0.5% and phenylephrine 10% ( VISUMIDRIATIC FENILEFRINA) at 30, 20, and 10 min prior to surgery.
Intervention: Efficacy of a Standardized Intracameral Combination of Mydriatics and Anesthetic (Mydrane ®) for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma
Group 2: Insert Device Mydriasert®
Group 2 patients had the Mydriasert® (Phenylephrine Hydrochloride,Tropicamide) device placed in the inferior conjunctival sac at least 1 h before surgery
Intervention: Efficacy of a Standardized Intracameral Combination of Mydriatics and Anesthetic (Mydrane ®) for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma
Group 3: Intracameral Anesthesia Mydrane®
Group 3 patients received 0.2 mL intracameral Mydrane®(0.2 mg/ml + 3.1 mg/ml + 10 mg/ml tropicamide, lidocaine hydrochloride, phenylephrine hydrochloride) immediately following the clear corneal incision; the surgeon allowed 45-60 s for adequate pupil dilation before performing continuous curvilinear capsulorhexis (CCC)
Intervention: Efficacy of a Standardized Intracameral Combination of Mydriatics and Anesthetic (Mydrane ®) for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma
Outcomes
Primary Outcomes
Stability of mydriasis
Time Frame: 1 hour
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.
Duration of surgery
Time Frame: 1 hour
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).
Secondary Outcomes
- Pain experience(up to 4 weeks)
- Central corneal thickness (CCT) and corneal endothelium cell density (CD) changes(up to 4 weeks)
- Visual field defects(up to 4 weeks)
- Anterior segment parameters variations(up to 4 weeks)