Retinopathy of PrematurityNCT05880433
The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations
An observational study of Retinopathy of Prematurity and Mydriasis, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Retinopathy of prematurity (ROP) is a retinal disorder of preterm neonates and a potential cause of blindness. As early diagnosis and treatment preserve vision, very low birth weight infants must be screened for ROP. Mydriatic eye drop administration is essential to perform funduscopic evaluations. Read more about this study
- Who is it for?
- Ages 28 to 31 days
- Conditions the study is for
- Retinopathy of Prematurity, Mydriasis, Neonatal Disease
- What is being tested?
- NIRS(INVOS 5100; Covidien Somanetics, Troy, MI
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 30 Nov 2022
- Phase
- Observational
- 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 28 to 31 days
- All sexes
- No healthy volunteers
- Child
Study population: Sixty two infants with a gestational age below 34 weeks and/or with a birth weight of less than 2000 g. were included in the study. The infants who underwent the initial retinopathy screening exam and did not need any respiratory support at the time of the examination were included. The neonates with congenital anomaly, sepsis, hemodynamic instability and intraventricular hemorrhage were excluded.
Who may be able to join
- Babies born at gestational age less than 34 weeks and/or birth weight below 2000 grams.
- Infants undergoing their first retinopathy examination.
Who cannot join
- Congenital anomaly
- Continued mechanical ventilation support
- Having pain from a different cause and/or requiring concurrent analgesic use
- Sedation analgesia administered within the last 24 hours
- Hemodynamically unstable
- Intraventricular hemorrhage, neurological dysfunction
- Receiving anticonvulsant therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mydriatic Eye Drops on Cerebral Blood Flow and Oxygenation in Retinopathy of Prematurity Examinations: A Prospective Observational Trial
Retinopathy of prematurity (ROP) is a retinal disorder of preterm neonates and a potential cause of blindness. As early diagnosis and treatment preserve vision, very low birth weight infants must be screened for ROP. Mydriatic eye drop administration is essential to perform funduscopic evaluations. The most commonly used mydriatic drops for pupil dilatation are 0.5-1.0% tropicamide and/or 0.5-1.0% phenylephrine or 0.2-1.0% cyclopentolate. Phenylephrine, an alpha-1 sympathomimetic agonist, is readily absorbed from conjunctival mucosa and has a potent systemic vasopressor effect. Tropicamide causes cycloplegia by inhibition of ciliary muscle contraction and has a short acting para-sympatholytic effect.
Systemic absorption of mydriatic eye drops has been associated with cardiovascular, respiratory and gastrointestinal adverse effects. Systemic side effects include apnea, desaturation, increased heart rate and blood pressure, delayed gastric emptying, and feeding intolerance. The data about the effects of mydriatics on cerebral blood flow and tissue oxygenation are sparse. Cerebral blood flow autoregulation depends in part on the adrenergic and cholinergic control of cerebral vasculature, but whether mydriatics have an effect on cerebral haemodynamics is unknown. Near-infrared spectroscopy and Doppler ultrasonography (US) are non-invasive methods commonly used for neuromonitorization in NICUs. The regional blood flow changes measured using Doppler US have been reported to be associated with cerebral oxygenation and indicate a high correlation with NIRS in newborns.
The aim of this study was to evaluate the effects of mydriatic eye drops on cerebral oxygenation and blood flow in preterm infants by NIRS and Doppler US.
- Being tested
- NIRS(INVOS 5100; Covidien Somanetics, Troy, MI
- Keywords
- Cerebral blood flow, Cerebral oxygenation, Mydriatic eye drops, Doppler ultrasonography, Retinopathy of prematurity, NIRS, Neonate
- Medical subject headings
- Retinopathy of Prematurity, Mydriasis, Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS(INVOS 5100; Covidien Somanetics, Troy, MIDevice
NIRS (Near Infrared Spectroscopy) is a non-invasive, bedside device that measures the concentration of oxygenated and deoxygenated hemoglobin in tissue, providing information about tissue oxygenation. Its working mechanism is based on the ability of light with wavelengths between 700-1000 nm to penetrate up to 8 cm into the skin and brain tissue. It offers continuous information about tissue oxygenation in different regions using probes attached to the skin. While pulse oximeters indicate arterial oxygen saturation, they are insufficient in detecting tissue-level hypoxia. Therefore, NIRS, being a painless method, is frequently used in the monitoring of newborns in the intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Before Eye drop instillation | For pupil dilatation, one drop of 2.5% phenylephrine hydrochloride and 0.5% tropicamide was instilled three times at 5 minute intervals, 1 hour before the exam. All infants were fed 1 hour before instillation of drops and infants were swaddled before the procedure. Receives: Device: NIRS(INVOS 5100; Covidien Somanetics, Troy, MI | |
| After Eye drop instillation | The same participiants investigated after eye drop instillation Receives: Device: NIRS(INVOS 5100; Covidien Somanetics, Troy, MI |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIRS
Absolute change in rScO2 after mydriatic eye drops instillation with NIRS
Measured: Data were started to get recorded 60 minutes before the instillation of eye drops for pupil dilation. The recording was continued uninterruptedly till 1 hour after the instillation through study completion, an average of 2 hours.
Doppler US measurements
Absolute change in MCA blood flow after mydriatic eye drops instillation with Doppler USG
Measured: The initial and second assessment were conducted before the application and at the 60th minute of instillation of the first drop, respectively - an average of 2 hours.
Secondary outcomes (3)
Changes in heart rate (beats per minute)
Heart rate was recorded continuously, starting 60 minutes before and after mydriatic eye drop instillation.
Measured: starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.
Changes in blood pressure
Mean arterial pressure values was recorded for every 5 minutes, starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.
Measured: Starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.
Changes in oxygen saturation.
Oxygen saturation was recorded continuously, starting 60 minutes before and after mydriatic eye drop instillation, through study completion, an average of 2 hours.
Measured: Starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 May 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Didem Arman, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880433
- Sponsor's protocol ID
- IstanbulTRH-DArman-001
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 30 May 2023
- 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 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mydriatic Eye Drops on Cerebral Blood Flow and Oxygenation in Retinopathy of Prematurity Examinations: A Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT05880433
- Acronym / sponsor ID
- IstanbulTRH-DArman-001
- Keywords
- Cerebral blood flow, Cerebral oxygenation, Mydriatic eye drops, Doppler ultrasonography, Retinopathy of prematurity, NIRS, Neonate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 30 May 2023 (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.
Retinopathy of prematurity (ROP) is a retinal disorder of preterm neonates and a potential cause of blindness. As early diagnosis and treatment preserve vision, very low birth weight infants must be screened for ROP. Mydriatic eye drop administration is essential to perform funduscopic evaluations. The most commonly used mydriatic drops for pupil dilatation are 0.5-1.0% tropicamide and/or 0.5-1.0% phenylephrine or 0.2-1.0% cyclopentolate. Phenylephrine, an alpha-1 sympathomimetic agonist, is readily absorbed from conjunctival mucosa and has a potent systemic vasopressor effect. Tropicamide causes cycloplegia by inhibition of ciliary muscle contraction and has a short acting para-sympatholytic effect.
Systemic absorption of mydriatic eye drops has been associated with cardiovascular, respiratory and gastrointestinal adverse effects. Systemic side effects include apnea, desaturation, increased heart rate and blood pressure, delayed gastric emptying, and feeding intolerance. The data about the effects of mydriatics on cerebral blood flow and tissue oxygenation are sparse. Cerebral blood flow autoregulation depends in part on the adrenergic and cholinergic control of cerebral vasculature, but whether mydriatics have an effect on cerebral haemodynamics is unknown. Near-infrared spectroscopy and Doppler ultrasonography (US) are non-invasive methods commonly used for neuromonitorization in NICUs. The regional blood flow changes measured using Doppler US have been reported to be associated with cerebral oxygenation and indicate a high correlation with NIRS in newborns.
The aim of this study was to evaluate the effects of mydriatic eye drops on cerebral oxygenation and blood flow in preterm infants by NIRS and Doppler US.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before Eye drop instillation | – | Device: NIRS(INVOS 5100; Covidien Somanetics, Troy, MIFor pupil dilatation, one drop of 2.5% phenylephrine hydrochloride and 0.5% tropicamide was instilled three times at 5 minute intervals, 1 hour before the exam. All infants were fed 1 hour before instillation of drops and infants were swaddled before the procedure. |
| After Eye drop instillation | – | Device: NIRS(INVOS 5100; Covidien Somanetics, Troy, MIThe same participiants investigated after eye drop instillation |
Who may qualify
- Ages
- 28 to 31 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Sixty two infants with a gestational age below 34 weeks and/or with a birth weight of less than 2000 g. were included in the study. The infants who underwent the initial retinopathy screening exam and did not need any respiratory support at the time of the examination were included. The neonates with congenital anomaly, sepsis, hemodynamic instability and intraventricular hemorrhage were excluded.
Key inclusion criteria (2 listed)
- Babies born at gestational age less than 34 weeks and/or birth weight below 2000 grams.
- Infants undergoing their first retinopathy examination.
Key exclusion criteria (7 listed)
- Congenital anomaly
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 |
|---|---|---|
| NIRS(INVOS 5100; Covidien Somanetics, Troy, MINIRS (Near Infrared Spectroscopy) is a non-invasive, bedside device that measures the concentration of oxygenated and deoxygenated hemoglobin in tissue, providing information about tissue oxygenation. Its working mechanism is based on the ability of light with wavelengths between 700-1000 nm to penetrate up to 8 cm into the skin and brain tissue. It offers continuous information about tissue oxygenation in different regions using probes attached to the skin. While pulse oximeters indicate arterial oxygen saturation, they are insufficient in detecting tissue-level hypoxia. Therefore, NIRS, being a painless method, is frequently used in the monitoring of newborns in the intensive care unit. | Device | After Eye drop instillation, Before Eye drop instillation |
Primary outcome
NIRS
Time frame: Data were started to get recorded 60 minutes before the instillation of eye drops for pupil dilation. The recording was continued uninterruptedly till 1 hour after the instillation through study completion, an average of 2 hours.
Absolute change in rScO2 after mydriatic eye drops instillation with NIRS
Doppler US measurements
Time frame: The initial and second assessment were conducted before the application and at the 60th minute of instillation of the first drop, respectively - an average of 2 hours.
Absolute change in MCA blood flow after mydriatic eye drops instillation with Doppler USG
3 secondary outcomes
Changes in heart rate (beats per minute)
Time frame: starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.
Changes in blood pressure
Time frame: Starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 hours.
Changes in oxygen saturation.
Time frame: Starting 60 minutes before and after mydriatic eye drop instillation,through study completion, an average of 2 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 30 May 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Retinopathy of Prematurity and Mydriasis, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
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 7 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 30 May 2023. 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 Turkey (Türkiye). 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.
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?
NIRS (time frame: Data were started to get recorded 60 minutes before the instillation of eye drops for pupil dilation. The recording was continued uninterruptedly till 1 hour after the instillation through study completion, an average of 2 hours.). The study lists 2 primary outcomes in all. 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 30 May 2023.