CataractPhase 4NCT04880928
Comparison Mydriasis by Mydrane With Topical Drop Application
A Phase 4 study testing Eye injection (Mydrane), eye drops (Phenylephrin) and eye drops (Tropicamid) in people with Cataract, run by Medical University of Graz at 1 site in Austria.
Trial 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%). Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Cataract
- What is being tested?
- Eye injection (Mydrane), eye drops (Phenylephrin) and eye drops (Tropicamid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- 12 Aug 2020to 23 Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Intraindividual Comparison of the Mydriasis of a Standardized Intracameral Anaesthetics With the Topical Preoperative Drop Application in the Uncomplicated Cataract Surgery
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.
- Conditions
- Cataract
- Being tested
- Eye injection (Mydrane), eye drops (Phenylephrin), eye drops (Tropicamid)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye injection (Mydrane)Drug
Also called Mydrane
Mydrane 0.2 mg/ml + 3.1 mg/ml
+ 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride
eye drops (Phenylephrin)Drug
Also called Minims
Phenylephrine 10%
eye drops (Tropicamid)Drug
Also called Agepha
Tropicamid 0,5%
| Study group | Role | What they receive |
|---|---|---|
| injection solution | Experimental | Mydrane, Tropicamid 0,02%, Phenylephrine 0,31%, Lidocain 1%, injection solution Receives: Drug: Eye injection (Mydrane) |
| Standard eye Drops | Active comparator | Phenylephrine 10% and Tropicamid 0,5% eye drops Receives: Drug: eye drops (Phenylephrin); Drug: eye drops (Tropicamid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupil dilating
The frequency of the feasibility of capsulorhexis without additional pupil dilating actions
Measured: during first and second surgery: a maximum of four weeks between first and second surgery
Secondary outcomes (2)
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
Measured: after first and second surgery: a maximum of four weeks between first and second surgery
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
Measured: after first and second surgery: a maximum of four weeks between first and second surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start12 Aug 2020
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880928
- Sponsor's protocol ID
- Mydriasis with Mydrane
- Status last verified
- Oct 2021
- First submitted
- 5 May 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Intraindividual Comparison of the Mydriasis of a Standardized Intracameral Anaesthetics With the Topical Preoperative Drop Application in the Uncomplicated Cataract Surgery
- ClinicalTrials.gov ID
- NCT04880928
- Acronym / sponsor ID
- Mydriasis with Mydrane
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injection solution | Experimental | Drug: Eye injection (Mydrane)Mydrane, Tropicamid 0,02%, Phenylephrine 0,31%, Lidocain 1%, injection solution |
| Standard eye Drops | Active comparator | Drug: eye drops (Phenylephrin), Drug: eye drops (Tropicamid)Phenylephrine 10% and Tropicamid 0,5% eye drops |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye injection (Mydrane)Also: MydraneMydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml solution for injection tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride | Drug | injection solution |
| eye drops (Phenylephrin)Also: MinimsPhenylephrine 10% | Drug | Standard eye Drops |
| eye drops (Tropicamid)Also: AgephaTropicamid 0,5% | Drug | Standard eye Drops |
Primary outcome
pupil dilating
Time frame: during first and second surgery: a maximum of four weeks between first and second surgery
The frequency of the feasibility of capsulorhexis without additional pupil dilating actions
2 secondary outcomes
subjective highest intraoperative pain
Time frame: after first and second surgery: a maximum of four weeks between first and second surgery
subjective perception of anesthetic procedures
Time frame: after first and second surgery: a maximum of four weeks between first and second surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Cataract
RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eye injection (Mydrane), eye drops (Phenylephrin) and eye drops (Tropicamid) in people with Cataract, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pupil dilating (time frame: during first and second surgery: a maximum of four weeks between first and second surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.