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

Primary Purpose

Cataract Surgery

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Efficacy of a Standardized Intracameral Combination of Mydriatics and Anesthetic (Mydrane ®) for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Surgery focused on measuring mydriasis and intraocular anaesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Policlinico Gemelli

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group 1: Mydriatic Eyedrops

Group 2: Insert Device Mydriasert®

Group 3: Intracameral Anesthesia Mydrane®

Arm Description

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.

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

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)

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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".
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.
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.
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).

Full Information

First Posted
February 1, 2023
Last Updated
July 4, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05925894
Brief Title
Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma.
Acronym
MIGA
Official Title
Efficacy of the Intracamerally Administered Mydriatics for Cataract Surgery in Patients With Primary Open-angle Glaucoma.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
December 18, 2021 (Actual)
Study Completion Date
January 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
Keywords
mydriasis and intraocular anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this retrospective study, we collected pre- and post-operative data from 60 patients who underwent elective cataract extractions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Mydriatic Eyedrops
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2: Insert Device Mydriasert®
Arm Type
Experimental
Arm Description
Group 2 patients had the Mydriasert® (Phenylephrine Hydrochloride,Tropicamide) device placed in the inferior conjunctival sac at least 1 h before surgery
Arm Title
Group 3: Intracameral Anesthesia Mydrane®
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Efficacy of a Standardized Intracameral Combination of Mydriatics and Anesthetic (Mydrane ®) for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma
Intervention 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.
Primary Outcome Measure Information:
Title
Stability of mydriasis
Description
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
Title
Duration of surgery
Description
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
Secondary Outcome Measure Information:
Title
Pain experience
Description
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
Title
Central corneal thickness (CCT) and corneal endothelium cell density (CD) changes
Description
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.
Time Frame
up to 4 weeks
Title
Visual field defects
Description
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
Title
Anterior segment parameters variations
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
francesco ricci
Organizational Affiliation
policlinico gemelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32126990
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.
Results Reference
result

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

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