Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial

Administrative information

Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).

Title {1}	Digital therapeutics Approach for Young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial.
Trial registration {2a and 2b}.	ClinicalTrials.gov: NCT06344572; date of registration: April 12, 2024 (retrospectively registered).
Protocol version {3}	Version 2.0, April 23, 2024
Funding {4}	S-Alpha Therapeutics, Inc. provided funding for this clinical trial.
Author details {5a}	Hae Jung Paik1*, Byung Joo Lee2, DongHuiLim3, So Young Han4, Eun Hye Jung5, Hyun Jin Shin6, Hyun Kyung Kim7, Ungsoo Samuel Kim8, Won Jae Kim9, Hee Young Choi10, JihaePark11, Soolienah Rhiu12, Jihye Lee13, Moonjeong Kim13, andKyungheeKim13 1 Department of Ophthalmology, Gachon University Gil Medical Center, Incheon, Republic of Korea 2 Department of Ophthalmology, Asan Medical Center, Seoul, Republic of Korea 3 Department of Ophthalmology, Samsung Medical Center, Seoul, Republic of Korea 4 Department of Ophthalmology, Kangbuk Samsung Hospital, Seoul, Republic of Korea 5 Department of Ophthalmology, Nowon Eulji Medical Center, Seoul, Republic of Korea 6 Department of Ophthalmology, Konkuk University Medical Center, Seoul, Republic of Korea 7 Department of Ophthalmology, HanGil Eye Hospital, Incheon, Republic of Korea 8 Department of Ophthalmology, Chung-Ang University Gwangmeyong Hospital, Gwangmeyong, Republic of Korea 9 Department of Ophthalmology, Yeungnam University Medical Center, Daegu, Republic of Korea, 10 Department of Ophthalmology, Pusan National University Hospital, Busan, Republic of Korea, 11 Department of Ophthalmology, Daegu Fatima Hospital, Daegu, Republic of Korea 12 Department of Ophthalmology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea 13 S-Alpha Therapeutics, Inc., Seoul, Republic of Korea *Correspondence to Professor Hae Jung Paik, Department of Ophthalmology, Gachon University Gil Medical Center, Incheon, Republic of Korea
Name and contact information for the trial sponsor {5b}	S-Alpha Therapeutics, Inc. 17th F., 311, Gangnam-daero, Seocho-gu, Seoul, Republic of Korea [email protected]  + 82–2–3487–3923
Role of sponsor {5c}	The sponsor is responsible for research sponsorship and funding, has participated in the study design, and holds the decision making and...