Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063023) titled 'Short-term clinical study to evaluate changes in ocular reaction under various visual conditions' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - The University of Osaka
Condition:
Condition - Myopia and myopic astigmatism
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the relationship between Quality of Vision (QOV) and myopia control efficacy by evaluating choroidal thickness and accommodation under different visual conditions.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Study Day 1: Participants will view an unprocessed, clear video image.
Study Day 2 (on a different day from Day 1): Participants will view a video image processed with a blur equivalent to +1.00 diopter defocus.
Eligibility:
Age-lower limit - 7
years-old
Gender - Male and Female
Key inclusion criteria - Individuals who have provided written informed consent to participate in the study.
Key exclusion criteria - - having any ocular diseases requiring treatment other than for refractive errors (e.g., dry eye disease, allergic eye diseases).
- having the history of any ocular surgeries that may affect visual acuity (e.g., corneal transplantation, corneal refractive surgery, retinal detachment surgery).
- having corneal diseases associated with irregular astigmatism that may affect visual acuity (e.g., keratoconus).
- having the history of any myopia control treatment within the past 12 months (e.g., orthokeratology, atropine eye drops, multifocal spectacles, multifocal contact lenses, dietary supplements).
- having a best-corrected visual acuity of less than 0.8 (decimal).
- cylindrical power of subjective refraction is greater than -1.50 D.
- spherical power of subjective refraction is outside the range of +2.00 D to -6.00 D.
- anisometropia greater than 1.50 D.
- having the history of participating another clinical study that may affect visual acuity within the past 30 days.
Target Size - 30
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 10 Month 21 Day
Date of IRB - 2024 Year 10 Month 21 Day
Anticipated trial start date - 2024 Year 11 Month 20 Day
Last follow-up date - 2026 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072115
Disclaimer: Curated by HT Syndication.