search
Back to results

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
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 5, 2021
Last Updated
October 11, 2021
Sponsor
Medical University of Graz
search

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

Learn more about this trial

Comparison Mydriasis by Mydrane With Topical Drop Application

We'll reach out to this number within 24 hrs