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Eye and Growth in Adolescents Born Moderate-to-late Preterm

Ocular Morphology and Visual Function in Relation to Growth, Metabolic, Cardiovascular, and Neuropsychiatric Status, and Quality of Life in Adolescents Born Moderate-to-late Preterm

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04190147
Enrollment
100
Registered
2019-12-09
Start date
2019-10-28
Completion date
2021-10-01
Last updated
2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Abnormalities, Preterm Birth, Visual Impairment

Keywords

Moderate-to-late preterm

Brief summary

During recent years, the interest in studying the risks of being born moderate-to-late preterm (MLP), defined as birth between gestational week 32 to 36, has increased. Today the investigators know that morbidity and mortality are significantly higher in these individuals compared to individuals born full-term. However, few studies have focused on the development of the eye in MLP individuals. The purpose of the study is to evaluate eye morphology and visual function in relation to growth, metabolism, blood pressure, neuropsychiatric factors, and quality of life in adolescents born MLP. The results of the examinations will be compared to an age-matched control group. The study will evaluate the structural, functional, and metabolic aspects of the eye with the hypothesis that early eye abnormalities may detect the risk of developing metabolic and cardiovascular diseases.

Interventions

OTHERStructural, functional and metabolic eye examinations

Structural, functional and metabolic eye examinations

Sponsors

Vastra Gotaland Region
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Born moderate-to-late preterm. * Born in Gothenburg, Sweden. * Born between years 2002 and 2004.

Exclusion criteria

* Chromosomal abnormalities. * Syndromes. * Severe malformations. * Asphyxia. * Language difficulties. * Psychosocial problems at birth. * Severe maternal illness.

Design outcomes

Primary

MeasureTime frameDescription
Optic disc area.Through study completion, an average of 6 monthsOptic disc area measured with Optical coherence tomography (OCT, Topcon).
Visual acuity.Through study completion, an average of 6 months.Visual acuity measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scores.
Blood pressure.Through study completion, an average of 6 months.Systolic and diastolic blood pressure measured with blood pressure cuffs.
Blood concentration of Hemoglobin A1c (HbA1c).Through study completion, an average of 6 months.Blood samples of HbA1c.
Autism Spectrum Screening Questionnaire (ASSQ).Through study completion, an average of 6 months.The ASSQ consists of 27 items and is scored using a likert scale, with the following alternatives: not true (0 points), somewhat true (1 point) and certainly true (2 points).
Pediatric Quality of Life Inventory (PedsQL).Through study completion, an average of 6 months.PedsQL is a questionnaire measuring health-related quality of life in children and adolescents aged 2 to 18 years. It consists of 23 items including physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). It has a 5-point response scale: never a problem (0 points), almost never a problem (1 point), sometimes a problem (2 points), often a problem (3 points), almost always a problem (4 points).
Weight.Through study completion, an average of 6 monthsWeight measured in kilograms.
The Swanson, Nolan, and Pelham Rating Scale (SNAP-IV).Through study completion, an average of 6 months.Screening questionnaire for attention deficit hyperactivity disorder (ADHD) consisting of 26 items rated on a 4-point scale: not at all (0 points), just a little (1 point), quite a bit (2 points) and very much (3 points).
Refraction.Through study completion, an average of 6 months.Visual refraction measured with an autorefractor (Topcon).
Height.Through study completion, an average of 6 months.Height measured in meters.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026