Nearsightedness Clinical Trials

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Functional Vision and Quality of Life in a Modern Society - With Emphasis on Myopia and Cerebral Visual Impairment Among Youth

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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Society has become increasingly digital, and many everyday services have been replaced by digital self-service solutions.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
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: t
View:

• Healthy children

Locations
Other Locations
Sweden
Örebro university hospital
RECRUITING
Örebro
Contact Information
Primary
Alexandra UC Wrede, MD
alexandra.wrede@regionorebrolan.se
+358400791907
Time Frame
Start Date: 2024-10-27
Estimated Completion Date: 2029-05-30
Participants
Target number of participants: 300
Treatments
Healthy children 0-17 years
The study group will consist of 300 participants aged 0-17 years, divided into the following age-based subgroups corresponding to the PedEyeQ versions: 0-4 years, 5-11 years, and 12-17 years, with 100 participants in each group. Efforts will be made to ensure that sex distribution, ethnicity, socioeconomic status, and birth parameters reflect those of the general population. Recruitment will primarily take place through child health centers, preschools, and schools in Örebro and surrounding areas.
Related Therapeutic Areas
Sponsors
Leads: Region Örebro County
Collaborators: Göteborg University, Sahlgrenska University Hospital

This content was sourced from clinicaltrials.gov