- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925894
Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma. (MIGA)
July 4, 2023 updated by: Ricci Francesco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Efficacy of the Intracamerally Administered Mydriatics for Cataract Surgery in Patients With Primary Open-angle Glaucoma.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Roma, Italy, 00168
- Policlinico Gemelli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
|
Experimental: 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
|
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.
|
Experimental: 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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 hour
|
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).
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual field defects
Time Frame: up to 4 weeks
|
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.
|
up to 4 weeks
|
Anterior segment parameters variations
Time Frame: up to 4 weeks
|
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).
|
up to 4 weeks
|
Pain experience
Time Frame: up to 4 weeks
|
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".
|
up to 4 weeks
|
Central corneal thickness (CCT) and corneal endothelium cell density (CD) changes
Time Frame: up to 4 weeks
|
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.
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: francesco ricci, Policlinico Gemelli
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2021
Primary Completion (Actual)
December 18, 2021
Study Completion (Actual)
January 9, 2022
Study Registration Dates
First Submitted
February 1, 2023
First Submitted That Met QC Criteria
June 22, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 4, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4654
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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