Retinopathy of Prematurity (ROP)LTOO-XPNCT06649513
Long-term Ophthalmic Outcomes in Ex-premature Infants
An observational study of Retinopathy of Prematurity (ROP) and Premature Birth, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
There is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely. This study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Retinopathy of Prematurity (ROP), Premature Birth
- What is being tested?
- eye drops (Tropicamid)
- How many people
- 210 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2024to 1 Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Premature patients who were eligible for ROP screening, who were admitted to Erasmus MC between 1991 and 2007.
Who may be able to join
- Subjects eligible for ROP screening, and admitted to Erasmus MC between 1991 and 2007.
Who cannot join
- Subjects born after 2008,
- Subject has passed away before the start of the study
- Subject resides outside of the Netherlands
- Subject has a physical or mental disability that makes it impossible to participate in a routine eye exam, or has a disability that classifies the subject as an incapacitated adult.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Erasmus MC
Rotterdam, South Holland, 3015 GD
Angela Arends-Tjiam, Dr, +31653616960, a.arends-tjiam@erasmusmc.nl
Lizanne Derks, BSc, +31653901136, l.derks@erasmusmc.nl
About this study
There is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely. This study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood.
Read the detailed description
Every year, around 18.000 children in the Netherlands are born prematurely, which means that they were born before 37 weeks gestational age. The WHO defines three different categories of prematurity: moderate to late preterm (32-37 weeks), very preterm (<32-28 weeks), and extremely preterm (<28 weeks). Preterm birth is associated with numerous health problems, which can have both short-term and long-term consequences on the development of the child. A relatively rare complication of (very or extreme) preterm birth is lifelong visual impairment or blindness due to retinal detachment as a result of prematurity retinopathy (ROP). ROP is a vasoproliferative condition that affects the vessels in the retina. An inventory study shows that 305 children were diagnosed with ROP in the Netherlands in 2017. The majority of these children experienced spontaneous regression of the condition, but 13% of cases required treatment to prevent retinal detachment. In the long-term, ROP predisposes for ocular conditions such as visual field abnormalities, refractive error, strabismus, amblyopia, glaucoma and retinal detachment. However, research also indicates that prematurity, regardless of ROP diagnosis, can also be associated with adverse ophthalmological outcomes such as refractive error, strabismus, amblyopia and cerebral visual impairment (CVI). Although there are various publications on the ophthalmological outcomes of ROP and prematurity at school-age, less is known about these outcomes in the adult population. This study aims to investigate the anatomy and functionality of the eye in ex-premature infants who were born between 1991 and 2006. In addition, the differences in outcomes between ex-premature infants with and without ROP, and the differences in outcomes between treated and spontaneously regressed ROP, will be studied.
- Conditions
- Retinopathy of Prematurity (ROP), Premature Birth
- Being tested
- eye drops (Tropicamid)
- Keywords
- Retinopathy of Prematurity, Preterm birth, Visual acuity, Visual outcomes, Long term outcomes
- 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.
eye drops (Tropicamid)Diagnostic test
Mydriatic + cycloplegic eye drops are given to measure refractive error and to image the full retina.
| Study group | Role | What they receive |
|---|---|---|
| Preterm patients | Former patients who were born prematurely (GA < 37 weeks) Receives: Diagnostic Test: eye drops (Tropicamid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured with ETDRS chart. Expressed in Logarithm of the Minimum Angle of Resolution (LogMAR)
Measured: The primary outcome measure will be assessed at one single visit to Erasmus MC. This one-off measurement will not be repeated, nor is there a specific time-frame for this measurement.
Secondary outcomes (1)
Biometric, refractive, fundus and Optical coherence tomography (OCT) data.
- Refraction (spherical equivalent) in dioptre (D) measured with an automatic refractometer.
- Optical biometry measurements (axial eye length in millimeters, lens thickness in millimeters, anterior chamber depth in millimeters) measured with an optical biometer.
- Intra-ocular pressure (IOP) in millimeter in mercury (mmHg) measured with a non-contact or contact tonometer.
- Visual field abnormalities measured with a Humphrey Field Analyzer (HFA), expressed as Visual Field Index (VFI), Mean Deviation (MD) and Pattern Standard Deviation (PSD) in decibels (dB).
- Macula thickness in micrometers (µm) measured on Optical coherence tomography (OCT) images.
- Any anatomical abnormalities of the retina and choroid seen on OCT of fundus images.
- Presence of ophthalmological diagnoses such as amblyopia or strabismus.
- Relevant (ophthalmological) medical history/ophthalmological diagnosis in the past.
- Self-reported health, educational level, screen time and activity level (questionnaire).
Measured: The secondary outcome measures will be assessed at one single visit to Erasmus MC. These one-off measurements will not be repeated, nor are there a specific time-frames for these measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela M. Arends-Tjiam, MD PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649513
- Sponsor's protocol ID
- 12793
- Acronym
- LTOO-XP
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We only plan to share anonymized and aggregated data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Ophthalmic Outcomes in Ex-premature Infants
- ClinicalTrials.gov ID
- NCT06649513
- Acronym / sponsor ID
- LTOO-XP / 12793
- Conditions
- Retinopathy of Prematurity (ROP), Premature Birth
- Keywords
- Retinopathy of Prematurity, Preterm birth, Visual acuity, Visual outcomes, Long term outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 18 Oct 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.
There is limited knowledge on ophthalmological outcomes in the adult population that was born prematurely. This study aims to evaluate the ophthalmic outcomes of ex-premature infants that have reached adolescence or adulthood.
Detailed description
Every year, around 18.000 children in the Netherlands are born prematurely, which means that they were born before 37 weeks gestational age. The WHO defines three different categories of prematurity: moderate to late preterm (32-37 weeks), very preterm (<32-28 weeks), and extremely preterm (<28 weeks). Preterm birth is associated with numerous health problems, which can have both short-term and long-term consequences on the development of the child. A relatively rare complication of (very or extreme) preterm birth is lifelong visual impairment or blindness due to retinal detachment as a result of prematurity retinopathy (ROP). ROP is a vasoproliferative condition that affects the vessels in the retina. An inventory study shows that 305 children were diagnosed with ROP in the Netherlands in 2017. The majority of these children experienced spontaneous regression of the condition, but 13% of cases required treatment to prevent retinal detachment. In the long-term, ROP predisposes for ocular conditions such as visual field abnormalities, refractive error, strabismus, amblyopia, glaucoma and retinal detachment. However, research also indicates that prematurity, regardless of ROP diagnosis, can also be associated with adverse ophthalmological outcomes such as refractive error, strabismus, amblyopia and cerebral visual impairment (CVI). Although there are various publications on the ophthalmological outcomes of ROP and prematurity at school-age, less is known about these outcomes in the adult population. This study aims to investigate the anatomy and functionality of the eye in ex-premature infants who were born between 1991 and 2006. In addition, the differences in outcomes between ex-premature infants with and without ROP, and the differences in outcomes between treated and spontaneously regressed ROP, will be studied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm patients | – | Diagnostic Test: eye drops (Tropicamid)Former patients who were born prematurely (GA < 37 weeks) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Premature patients who were eligible for ROP screening, who were admitted to Erasmus MC between 1991 and 2007.
Key inclusion criteria (1 listed)
- Subjects eligible for ROP screening, and admitted to Erasmus MC between 1991 and 2007.
Key exclusion criteria (4 listed)
- Subjects born after 2008,
- Subject has passed away before the start of the study
- Subject resides outside of the Netherlands
- Subject has a physical or mental disability that makes it impossible to participate in a routine eye exam, or has a disability that classifies the subject as an incapacitated adult.
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 drops (Tropicamid)Mydriatic + cycloplegic eye drops are given to measure refractive error and to image the full retina. | Diagnostic test | Preterm patients |
Primary outcome
Visual acuity
Time frame: The primary outcome measure will be assessed at one single visit to Erasmus MC. This one-off measurement will not be repeated, nor is there a specific time-frame for this measurement.
Measured with ETDRS chart. Expressed in Logarithm of the Minimum Angle of Resolution (LogMAR)
1 secondary outcome
Biometric, refractive, fundus and Optical coherence tomography (OCT) data.
Time frame: The secondary outcome measures will be assessed at one single visit to Erasmus MC. These one-off measurements will not be repeated, nor are there a specific time-frames for these measurements.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No. We only plan to share anonymized and aggregated data.
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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.
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 (ROP) and Premature Birth, run by Erasmus Medical Center at 1 site in Netherlands.
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 1 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: opening soon, as of the sponsor's last update on 18 Oct 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Arends-Tjiam, Dr (+31653616960, a.arends-tjiam@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: The primary outcome measure will be assessed at one single visit to Erasmus MC. This one-off measurement will not be repeated, nor is there a specific time-frame for this measurement.). 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 18 Oct 2024.