Long-term Ophthalmic Outcomes in Ex-premature Infants
- Sponsor
- Erasmus Medical Center
- Study ID
- NCT06649513
- Status
- Not Yet Recruiting
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Conditions
- Premature Birth
- Retinopathy of Prematurity (ROP)
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- eye drops (Tropicamid) — DIAGNOSTIC_TESTMydriatic + cycloplegic eye drops are given to measure refractive error and to image the full retina.
Study Details
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.
Key Dates
- First listed
- Oct 18, 2024
- Start date
- Nov 1, 2024
- Status verified
- Oct 2024
- Primary completion
- Nov 1, 2029
- Completion
- Nov 1, 2030
Study Design
- Enrollment
- 210 participants (estimated)
Arms
- Arm: Preterm patientsFormer patients who were born prematurely (GA \< 37 weeks)
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. ]
Central Contacts
- Angela Arends-Tjiam, Dr+31653616960
- Lizanne Derks, BSc+31653901136
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