Comparison Mydriasis by Mydrane With Topical Drop Application
Primary Purpose
Cataract
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Eye injection (Mydrane)
eye drops (Phenylephrin)
eye drops (Tropicamid)
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Male and female patients between the age of 50 to 100 years
- Day-hospital and inpatient care
- Clinically significant opacity of the lens with indication for cataract surgery on both eyes
- Lack of previous ophthalmic surgeries
- Lack of relevant ophthalmic conditions: Pseudoexfoliation syndrome, eye injuries, present inflammation (in terms of uveitis, endophthalmitis and iridocyclitis), restricted mydriasis (pupil diameter below 7mm after application of tropicamide 0.38% and phenylephrine HCL 2.5% - at preoperative examination), elevated intraocular pressure, alpha-receptor inhibitor intake (e.g. tamsulosin) due to impeded mydriasis
Exclusion Criteria:
- Allergic to phenylephrine, tropicamide, sodium metabisulfite, disodium edetate, sodium hydroxide, hydrochloric acid, lidocaine hydrochloride, sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate
- Allergic to anesthesia (amide type)
- Allergic to atropine derivates
- Heart disease, tachycardia, hypertensive crises
- Aneurism of big vessels
- Untreated hyperthyroidism
- Untreated closed angle glaucoma and narrow angles with tendencies to glaucoma by intake of mydriatic drugs
- Pregnancy, breast feeding and premenopausal women
Sites / Locations
- Medical University Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
injection solution
Standard eye Drops
Arm Description
Mydrane, Tropicamid 0,02%, Phenylephrine 0,31%, Lidocain 1%, injection solution
Phenylephrine 10% and Tropicamid 0,5% eye drops
Outcomes
Primary Outcome Measures
pupil dilating
The frequency of the feasibility of capsulorhexis without additional pupil dilating actions
Secondary Outcome Measures
subjective highest intraoperative pain
Highest intraoperative pain visualized on a visual analogue scale (VAS) asked by a questionnaire, with the minimum 1 and maximum 10 , where higher scores mean a worse outcome
subjective perception of anesthetic procedures
perception of anesthetic procedures visualized on a visual analogue scale (VAS) asked by a questionnaire, with the minimum 1 and maximum 10 , where higher scores mean a worse outcome
Full Information
NCT ID
NCT04880928
First Posted
May 5, 2021
Last Updated
October 11, 2021
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT04880928
Brief Title
Comparison Mydriasis by Mydrane With Topical Drop Application
Official Title
Prospective Intraindividual Comparison of the Mydriasis of a Standardized Intracameral Anaesthetics With the Topical Preoperative Drop Application in the Uncomplicated Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of the study is to compare the effectiveness of the intracameral application of Mydrane® (standardized combination of Tropicamide 0.02%, Phenylephrine 0.31% and Lidocaine 1%) with the preoperative topical application (Tropicamide 0.5% and Phenylephrine 10%). To evaluate the steadiness of the dilating effect on the pupil, the ratio of eyes without necessity for further pupil dilating procedures to perform the capsulorhexis is assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
injection solution
Arm Type
Experimental
Arm Description
Mydrane, Tropicamid 0,02%, Phenylephrine 0,31%, Lidocain 1%, injection solution
Arm Title
Standard eye Drops
Arm Type
Active Comparator
Arm Description
Phenylephrine 10% and Tropicamid 0,5% eye drops
Intervention Type
Drug
Intervention Name(s)
Eye injection (Mydrane)
Other Intervention Name(s)
Mydrane
Intervention Description
Mydrane 0.2 mg/ml + 3.1 mg/ml
+ 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride
Intervention Type
Drug
Intervention Name(s)
eye drops (Phenylephrin)
Other Intervention Name(s)
Minims
Intervention Description
Phenylephrine 10%
Intervention Type
Drug
Intervention Name(s)
eye drops (Tropicamid)
Other Intervention Name(s)
Agepha
Intervention Description
Tropicamid 0,5%
Primary Outcome Measure Information:
Title
pupil dilating
Description
The frequency of the feasibility of capsulorhexis without additional pupil dilating actions
Time Frame
during first and second surgery: a maximum of four weeks between first and second surgery
Secondary Outcome Measure Information:
Title
subjective highest intraoperative pain
Description
Highest intraoperative pain visualized on a visual analogue scale (VAS) asked by a questionnaire, with the minimum 1 and maximum 10 , where higher scores mean a worse outcome
Time Frame
after first and second surgery: a maximum of four weeks between first and second surgery
Title
subjective perception of anesthetic procedures
Description
perception of anesthetic procedures visualized on a visual analogue scale (VAS) asked by a questionnaire, with the minimum 1 and maximum 10 , where higher scores mean a worse outcome
Time Frame
after first and second surgery: a maximum of four weeks between first and second surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients between the age of 50 to 100 years
Day-hospital and inpatient care
Clinically significant opacity of the lens with indication for cataract surgery on both eyes
Lack of previous ophthalmic surgeries
Lack of relevant ophthalmic conditions: Pseudoexfoliation syndrome, eye injuries, present inflammation (in terms of uveitis, endophthalmitis and iridocyclitis), restricted mydriasis (pupil diameter below 7mm after application of tropicamide 0.38% and phenylephrine HCL 2.5% - at preoperative examination), elevated intraocular pressure, alpha-receptor inhibitor intake (e.g. tamsulosin) due to impeded mydriasis
Exclusion Criteria:
Allergic to phenylephrine, tropicamide, sodium metabisulfite, disodium edetate, sodium hydroxide, hydrochloric acid, lidocaine hydrochloride, sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate
Allergic to anesthesia (amide type)
Allergic to atropine derivates
Heart disease, tachycardia, hypertensive crises
Aneurism of big vessels
Untreated hyperthyroidism
Untreated closed angle glaucoma and narrow angles with tendencies to glaucoma by intake of mydriatic drugs
Pregnancy, breast feeding and premenopausal women
Facility Information:
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison Mydriasis by Mydrane With Topical Drop Application
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