Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Table 1 General procedure and monitoring process

		Study period
		Enrollment	Allocation	Intervention (phase 1)				Follow-up			Intervention (phase 2)				Termination	Unscheduled visit
Time point		–7~0 d^*	0 d	1st d^*	2~7d	8th d^*	9~30d	M1^*	M2	M3	1st d	2~7d	8th d	9~30d
*Enrollment*
Screening visit		×
Informed consent		×
Inclusion and exclusion criteria		×
History of myopia Intervention		×
Diet habits		×	×
Daily activity time distribution		×	×
CISS^†		×	×					×	×	×					×	×
Diagnosis		×						×	×	×
Randomization			×
Subject files		×						×	×	×
Adverse events				×	×	×	×	×	×	×	×	×	×	×	×	×
Quit in advance				×	×	×	×				×	×	×	×	×
Unscheduled visits								×	×	×						×
Allocation			×
*Interventions*
Meditation group (phase 1)	The first set of audio and video (1 h)			×		×
Meditation group (phase 1)	The second set of audio and video (15–20 min)				×		×
Control group (phase 1)	Chinese eye exercises			×	×	×	×
Control group (phase 2)	The first set of audio and video (1 h)										×		×
Control group (phase 2)	The second set of audio and video (15–20 min)											×		×
*Assessment*
Previous visual acuity		×	×
Current visual acuity		×	×	×	×	×	×	×	×	×	×	×	×	×	×	×
Diopter and astigmatism		×	×				×	×	×	×				×	×	×

*d day, M month, 1^st d the first day, 8^th d the eight day. †CISS Convergence Insufficiency Symptoms Survey

ISSN: 1745-6215