Retinopathy of PrematurityEarly Phase 1NCT06288321

A Study Investigating Whether Low Dose Eyedrops for Pupil Dilation is as Effective and Safe as Standard Dose Eyedrops in Examination for Retinopathy of Prematurity.

A Early Phase 1 study testing Microdrop Mydrin-P and Standard Mydrin-P in people with Retinopathy of Prematurity, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Retinopathy of Prematurity
What is being tested?: Microdrop Mydrin-P and Standard Mydrin-P
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteHong Kong
Study dates: 10 Aug 2022to 22 Mar 2023
Phase: Early Phase 1
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Neonates with estimated gestational age (EGA) at birth ≤32 weeks
Neonates with birth weight ≤1500g

Who cannot join

Neonates with severe clinical condition with unstable vital signs
Neonates with congenital anomalies, syndromic disease
Neonates with ophthalmological conditions such as eye infections, congenital eye anomalies, trauma
Neonates with conditions that are contraindicated to mydriatic use

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital
Hong Kong

Other trials in Hong Kong

About this study

Official title: Randomized Controlled Trial Comparing the Efficacy and Safety of Mydriatic Microdrops Over Standard Dose Mydriatics for Pupil Dilation in Retinopathy of Prematurity Examination

A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong. The aim of this study was to determine whether microdrops Mydrin-P demonstrates similar efficacy as standard Mydrin -P eyedrops applied to neonates undergoing retinopathy of prematurity (ROP) screening exams, also to ascertain the optimal time for eye examination after administration of mydriatics and assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ between microdrops and standard dose Mydrin-P.

Preterm infants were randomized to receive either the standard Mydrin-P eyedrops or the mydriatic microdrops which contained around one-third of the standard Mydrin-P dosage. The primary outcome measured whether a successful ROP examination was conducted. Secondary outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after eyedrops instillation and at the time of ROP exam as well as adverse effects followed by the mydriatics administration.

A total of 18 patients were enrolled in this study with total 46 episodes of ROP recorded. All episodes with microdrops instillation led to successful ROP exams. There was no statistically significant difference between standard eyedrops and microdrops in determining the success of ROP exam (p=0.233). Mean pupil diameter did not differ between the microdrops and standard eyedrops group. At the time of ROP exam, the mean pupil diameter was 5.47mm in the standard eyedrops group and 5.73mm in the microdrops group. The optimal time for ROP exam was 60 minutes to 120 minutes after first dose of mydriatic. Also there was no difference in the occurrence of systemic side effects when compared to standard Mydrin P drops.

Hence the study concluded that microdrops have similar efficacy and safety profile compared to standard Mydrin-P eyedrops.

Conditions: Retinopathy of Prematurity
Being tested: Microdrop Mydrin-P, Standard Mydrin-P
Keywords: Retinopathy of prematurity, Preterm, Retinopathy of prematurity screening, Microdrops, Mydrin P, Mydriatics
Medical subject headings: Retinopathy of Prematurity, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Microdrop Mydrin-PDrug
Microdrop Mydrin-P consists of around one third of the standard Mydrin-P drop size. Drop volume measurement was performed using a precision weight scale (Sartorius) with accuracy up to 0.001g. The microdrop administration was conducted via attachment of a 16 gauge needle to a 1ml syringe.
Standard Mydrin-PDrug
Standard Mydrin-P is the standard mydriatic used for retinopathy of prematurity exam as per our local usual practice.

Study groups in NCT06288321
Study group	Role	What they receive
Standard Mydrin-P Group	Placebo comparator	Subjects allocated to the Standard Mydrin P group will receive standard Mydrin-P (0.5% tropicamide / 0.5% phenylephrine HCl) which is the standard eyedrops used for dilation of pupil before retinopathy of prematurity examination. Receives: Drug: Standard Mydrin-P
Microdrop group	Experimental	Those allocated to the microdrop group will receive microdrop Mydrin-P for pupil dilation before retinopathy of prematurity exam. Receives: Drug: Microdrop Mydrin-P

What is being measured

The primary outcome is the main question the study is designed to answer.

Successfulness of a ROP exam
Primary outcome of the study was whether the ROP screening was successfully performed or not without additional eyedrops defined by the ophthalmologist conducting the exam.
Measured: From the start of pupil dilation to pupil examination which is around 2 to 3 hours

Secondary outcomes (9)

Pupil diameters
Pupil diameter (in millimetres, mm) was documented at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP). Two measurements were taken during each time, one by visual assessment, another one by pupillometer measurement.
Measured: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Heart rate
Heart rate at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP) were captured.
Measured: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Blood pressure
Blood pressure at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP) were captured.
Measured: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Oxygen saturation
Oxygen saturation at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP) were captured.
Measured: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Oxygen requirement
Oxygen requirement at baseline (before eyedrops are applied, T0), 30 minutes from first dose of eyedrop (T30), 60 minutes from first dose of eyedrop (T60), 120 minutes from first dose of eyedrop (T120) and at time of ROP exam (TROP) were captured.
Measured: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Episodes of vomiting
Episodes of vomiting were documented in the 24 hours after eyedrops administration and compared to the baseline which is the past 24 hours prior to the eyedrops exposure
Measured: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Volume of gastric residuals
Volume of gastric residuals were documented in the 24 hours after eyedrops administration and compared to the baseline which is the past 24 hours prior to the eyedrops exposure
Measured: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Episodes of apnoea
Episodes of apnoea were documented in the 24 hours after eyedrops administration and compared to the baseline which is the past 24 hours prior to the eyedrops exposure
Measured: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Episodes of periorbital blanching
Episodes of periorbital blanching were documented in the 24 hours after eyedrops administration and compared to the baseline which is the past 24 hours prior to the eyedrops exposure
Measured: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202222 Mar 2023

First posted1 Mar 2024
Study start10 Aug 2022
Primary completion22 Mar 2023
Study completion22 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
More trials run by The University of Hong KongThe sponsor's other registered studies.
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: Early Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06288321
Sponsor's protocol ID: UW22221
Status last verified: Feb 2024
First submitted: 18 Feb 2024
Last updated: 1 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)

All Retinopathy of Prematurity trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial Comparing the Efficacy and Safety of Mydriatic Microdrops Over Standard Dose Mydriatics for Pupil Dilation in Retinopathy of Prematurity Examination
ClinicalTrials.gov ID: NCT06288321
Acronym / sponsor ID: UW22221
Conditions: Retinopathy of Prematurity
Keywords: Retinopathy of prematurity, Preterm, Retinopathy of prematurity screening, Microdrops, Mydrin P, Mydriatics
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: The University of Hong KongUniversity, hospital or other
Study start: 10 Aug 2022 (actual)
Primary completion: 22 Mar 2023 (actual)
Study completion: 22 Mar 2023 (actual)
First posted: 1 Mar 2024 (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.

Hence the study concluded that microdrops have similar efficacy and safety profile compared to standard Mydrin-P eyedrops.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard Mydrin-P Group	Placebo comparator	Drug: Standard Mydrin-PSubjects allocated to the Standard Mydrin P group will receive standard Mydrin-P (0.5% tropicamide / 0.5% phenylephrine HCl) which is the standard eyedrops used for dilation of pupil before retinopathy of prematurity examination.
Microdrop group	Experimental	Drug: Microdrop Mydrin-PThose allocated to the microdrop group will receive microdrop Mydrin-P for pupil dilation before retinopathy of prematurity exam.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Neonates with estimated gestational age (EGA) at birth ≤32 weeks
Neonates with birth weight ≤1500g

Key exclusion criteria (4 listed)

Neonates with severe clinical condition with unstable vital signs
Neonates with congenital anomalies, syndromic disease
Neonates with ophthalmological conditions such as eye infections, congenital eye anomalies, trauma
Neonates with conditions that are contraindicated to mydriatic use

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
Microdrop Mydrin-PMicrodrop Mydrin-P consists of around one third of the standard Mydrin-P drop size. Drop volume measurement was performed using a precision weight scale (Sartorius) with accuracy up to 0.001g. The microdrop administration was conducted via attachment of a 16 gauge needle to a 1ml syringe.	Drug	Microdrop group
Standard Mydrin-PStandard Mydrin-P is the standard mydriatic used for retinopathy of prematurity exam as per our local usual practice.	Drug	Standard Mydrin-P Group

Primary outcome

Successfulness of a ROP exam
Time frame: From the start of pupil dilation to pupil examination which is around 2 to 3 hours
Primary outcome of the study was whether the ROP screening was successfully performed or not without additional eyedrops defined by the ophthalmologist conducting the exam.

9 secondary outcomes

Pupil diameters
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Heart rate
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Blood pressure
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Oxygen saturation
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Oxygen requirement
Time frame: From start of pupil dilation (baseline) to 120 minutes after pupil dilation, total time is 120 minutes.
Episodes of vomiting
Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Volume of gastric residuals
Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Episodes of apnoea
Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.
Episodes of periorbital blanching
Time frame: From start of pupil dilation (baseline) to 24 hours after pupil dilation, total time is 24 hours.

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 1 Mar 2024.
Individual participant dataSharing planned: No

Related trials for Retinopathy of Prematurity

RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Retinopathy of Prematurity (ROP)

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.

Khair Jalal study chair

Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Microdrop Mydrin-P and Standard Mydrin-P in people with Retinopathy of Prematurity, run by The University of Hong Kong at 1 site in Hong Kong.

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 2 inclusion and 4 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 1 Mar 2024. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Successfulness of a ROP exam (time frame: From the start of pupil dilation to pupil examination which is around 2 to 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06288321.

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 1 Mar 2024.