Clinical trial

Efficacy of the Intracamerally Administered Mydriatics for Cataract Surgery in Patients With Primary Open-angle Glaucoma.

Name

4654

Description

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.

Trial arms

Trial start

2021-03-18

Estimated PCD

2021-12-18

Trial end

2022-01-09

Status

Completed

Treatment

Efficacy of a Standardized Intracameral Combination of Mydriatics and Anesthetic (Mydrane ®) for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma

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.

Arms:

Group 1: Mydriatic Eyedrops, Group 2: Insert Device Mydriasert®, Group 3: Intracameral Anesthesia Mydrane®

Size

Primary endpoint

Stability of mydriasis

1 hour

Duration of surgery

1 hour

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this retrospective study, we collected pre- and post-operative data from 60 patients who underwent elective cataract extractions.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-07-06

1 organization

1 product

1 indication

Organization

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Product

Mydrane

Indication

Cataract Surgery