Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma.

NCT05925894 | Completed DMC

• 1 other identifier: 4654
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Surgery

Keywords

mydriasis and intraocular anaesthesia

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  1 hour

Secondary Outcomes (4)

• 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

Study Arms (3)

Group 1: Mydriatic Eyedrops

ACTIVE COMPARATOR

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.

Drug: 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®

EXPERIMENTAL

Group 2 patients had the Mydriasert® (Phenylephrine Hydrochloride,Tropicamide) device placed in the inferior conjunctival sac at least 1 h before surgery

Drug: 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®

EXPERIMENTAL

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)

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients with POAG requiring glaucoma surgery
• ocular trauma or infection
• other forms of glaucoma
• pseudo-exfoliation and exfoliation syndrome

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Gemelli

Roma, 00168, Italy

Location

Related Publications (1)

• 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.

  PMID: 32126990 RESULT

MeSH Terms

Conditions

Mydriasis

Interventions

Anesthetics

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• francesco ricci

  Policlinico Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: In this retrospective study, we collected pre- and post-operative data from 60 patients who underwent elective cataract extractions.

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: June 29, 2023
• Study Start: March 18, 2021
• Primary Completion: December 18, 2021
• Study Completion: January 9, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)