Clinical trial NCT05925894: Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma.
Official title: Efficacy of the Intracamerally Administered Mydriatics for Cataract Surgery in Patients With Primary Open-angle Glaucoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Surgery
Keywords: mydriasis and intraocular anaesthesia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this retrospective study, we collected pre- and post-operative data from 60 patients who underwent elective cataract extractions.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stability of mydriasis
timeFrame: 1 hour
measure: Duration of surgery
timeFrame: 1 hour
Secondary outcomes:
measure: Pain experience
timeFrame: up to 4 weeks
measure: Central corneal thickness (CCT) and corneal endothelium cell density (CD) changes
timeFrame: up to 4 weeks
measure: Visual field defects
timeFrame: up to 4 weeks
measure: Anterior segment parameters variations
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Gemelli
Study officials:
affiliation: Policlinico Gemelli
name: francesco ricci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labetoulle M, Behndig A, Tassignon MJ, Nuijts R, Mencucci R, Guell JL, Pleyer U, Szaflik J, Rosen P, Berard A, Chiambaretta F, Cochener-Lamard B; Intracameral Mydrane (ICMA), Ethics Group. Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients. BMC Ophthalmol. 2020 Mar 3;20(1):81. doi: 10.1186/s12886-020-01343-x.