Modified Defocus Incorporated Multiple Segments lens (D1)
OtherD1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously
NCT Number: NCT07547072
The goal of this study is to investigate the short-term changes in choroidal thickness and efficacy of the study spectacle lenses in children. Participants will be prescribed with a pair of study spectacle lenses for daily use and visit the clinic once every week for the first month for checkup and tests. After the first month of follow-up, participants will visit at 1 month, 6- and 12-month for checkup. Choroidal thickness, axial length and refractive errors will be monitored.
Trial opening soon.
Get Notified6 year–13 year
All sexes
Interventional
Not applicable
Optical interventions have been widely used for myopia control in children, however, the effectiveness varied between individuals. The current study spectacle lenses are modified based on DIMS technology.
Participants will be randomly allocated to single vision (SV) lens group (control), D1 or D2 group (treatment). The weekly choroidal thickness changes will be monitored in the first month of lens wear. Their cycloplegic refraction and axial length will be monitored every 6 months for 1 year.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
D1 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously
D2 is a modified Defocus Incorporated Multiple Segments lens that corrects the distance refraction and provides myopic defocus simultaneously
Time frame: Baseline, every week for 1 month, every 6 months over 1 year
Choroidal thickness will be measured by a swept source optical coherence tomographer. Changes in choroidal thickness from baseline over the first month and every 6 months for 1 year over the study period.
Time frame: Baseline, 6 and 12 months
Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 1 year over the study period.
Time frame: Baseline, 6 and 12 months
Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline every 6 months for 1 year over the study period.
Contact information is provided by the study sponsor or research team.
Dennis Yan Yin Tse, PhD
CONTACT
Rachel Ka Man Chun, PhD
CONTACT
The Hong Kong Polytechnic University
Other
Choroidal Responses to the Modified Defocus Incorporated Multiple Segments (DIMS) Spectacle Lenses
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07724210
Eye Diseases, Myopia
Beijing, Beijing Municipality, China
View Trial DetailsNCT07406906
Eye Diseases, Myopia
Hong Kong
View Trial DetailsNCT07721714
Astigmatism, Eye Diseases
Palo Alto, California, United States
View Trial DetailsNCT07696468
Eye Diseases, Myopia
Guangzhou, Guangdong, China
View Trial Details