NCT07653074 Functional Vision and Quality of Life in a Modern Society - With Emphasis on Myopia and Cerebral Visual Impairment Among Youth
| NCT ID | NCT07653074 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Örebro County |
| Condition | Myopia |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-10-27 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-10-27 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Society has become increasingly digital, and many everyday services have been replaced by digital self-service solutions. This puts greater demands on our vision and our ability to interpret what we see. At the same time, the number of children with nearsightedness (myopia) has increased rapidly. In some parts of Asia, as many as 60-70% of students in seventh grade are nearsighted (1), and a similar trend may develop in Europe. Nearsightedness is becoming a growing challenge in pediatric eye care. High myopia can lead to complications that require early detection and prevention. There are now several ways to slow down its progression, such as special contact lenses, glasses, and eye drops (2). However, the scientific evidence for these treatments varies, and there are currently no national or Nordic guidelines on how to use them. In addition, myopia may have a major impact on children's quality of life. Currently, there is no validated Swedish questionnaire that measures vision related quality of life across all age groups in children and adolescents. To address this, researchers in the United States developed the Pediatric Eye Questionnaire (PedEyeQ) in 2019 (3). It is already available in English and Spanish and takes into account both the child's and the parent's perspectives on vision and daily life. The aim of this study is to translate, culturally adapt and test the PedEyeQ in Swedish children and adolescents, and to investigate how common refractive errors, especially nearsightedness - are today compared to 20-30 years ago. The study will include 300 healthy children and adolescents aged 0-17 years, divided into three age groups: 0-4 years, 5-11 years, and 12-17 years. Participants will be recruited through child health centers, preschools, and schools in the Örebro region. All participants will visit the eye clinic for a detailed eye examination, including: * Testing distance and near visual acuity * Measuring eye refraction (with and without eye drops that temporarily relax the eye's focusing muscles) * Imaging the retina using Optical Coherence Tomography (OCT) * Measuring eye length and corneal shape * Checking eye pressure and contrast sensitivity Children and parents will also answer questions about how the child's vision affects everyday life and wellbeing. For the youngest children (0-4 years), only parents will answer the questions. The PedEyeQ will be translated into Swedish following the International Society for Pharmacoeconomics and Outcome Research (ISPOR) (4) guidelines to make sure it is culturally relevant and easy to understand. The Swedish version will then be tested to ensure it is accurate and reliable. All information collected in the study will be stored securely and anonymously. The results will also be compared with data from a similar cohort conducted in the 1990s to see if vision problems have become more common over time (5). This project will provide new knowledge about children's vision and quality of life in Sweden. A validated Swedish version of the PedEyeQ can be used both in healthcare and research to better understand how vision affects children's daily lives. The study will also offer updated information on the frequency of refractive errors among Swedish children and adolescents - knowledge that is essential for developing preventive strategies and improving eye care for the future.
Eligibility Criteria
Inclusion Criteria: * Healthy children Exclusion Criteria: * Children with ophthalmological diagnosis followed frequently by the ophthalmological clinic
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07653074 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07653074 currently recruiting?
Yes, NCT07653074 is actively recruiting participants. Contact the research team at alexandra.wrede@regionorebrolan.se for enrollment information.
Where is the NCT07653074 trial being conducted?
This trial is being conducted at Örebro, Sweden.
Who is sponsoring the NCT07653074 clinical trial?
NCT07653074 is sponsored by Region Örebro County. The trial plans to enroll 300 participants.