AR Training Versus Patching in Unilateral Amblyopia
ConditionAmblyopia Unilateral
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-55
SponsorEye & ENT Hospital of Fudan University
About this trial
This is a multi-center, randomized controlled trial to compare the effectiveness of AR training with patching for the treatment of unilateral amblyopia.
Specific Aim 1 (Primary): To compare the improvement of visual acuity in the amblyopic eye between AR training and patching for the treatment of unilateral amblyopia.
Specific Aim 2 (Secondary): To compare the improvement of visual functions between AR training and patching for the treatment of unilateral amblyopia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 5-55 years (including 5 years and 55 years);
Best-corrected visual acuity worse than 20/30 but no worse than 20/200 in the amblyopic eye, interocular difference of 2 or more lines, with the better eye within the normal range;
Patients have applied optical refractive correction for more than 3 months;
Ability attend visits and complete the treatment;
Disqualifiers
Organic eye diseases preventing the establishment of good vision (e.g. ptosis, media opacity, nystagmus, paracentral fixation, acute inflammation like keratitis, optic nerve diseases like glaucoma, retinal diseases);
Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment);
Implantable electronic device;
A history of ocular surgery (except strabismus surgery) affecting vision (e.g. retinal detachment repair);
Trial design
Design model
Parallel
Treatments tested in this trial
AR training
Other interventionDichoptic augmented reality training with dual-pathway (parvocellular pathway and magnocellular pathway) and interocular push-pull paradigms developed based on neural deficits in unilateral amblyopia.
Patching
Other interventionConventional patching therapy.
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: AR training groupExperimental treatment 1 intervention
Group B: Patching groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total effective rate
The effective rate is defined as the proportion of patients whose best-corrected visual acuity (BCVA) at distance improved ≥0.2 LogMAR after treatment compared to the baseline. BCVA at distance is measured with ETDRS chart.
Time frame
13 weeksSecondary outcomes
1
Change in best-corrected visual acuity
Best-corrected visual acuity is measured with cycloplegic refraction, using ETDRS chart.
Time frame
2 weeks, 4 weeks, 9 weeks, 13 weeks2
Effective rate
The effective rate is defined as the proportion of patients whose best-corrected visual acuity (BCVA) at distance improved ≥0.2 LogMAR after treatment compared to the baseline. BCVA at distance is measured with ETDRS chart.
Time frame
2 weeks, 4 weeks, 9 weeks3
Change in habitual visual acuity
Habitual visual acuity is measured under habitual refractive correction at a viewing distance of 4 meters, using ETDRS chart.
Time frame
2 weeks, 4 weeks, 9 weeks, 13 weeks4
Change in stereopsis
Near and far stereopsis measured with Randot Stereotest pattern.
Time frame
2 weeks, 4 weeks, 9 weeks, 13 weeksOther outcomes
1
Normal proportion in the worth-4 dot test
The proportion of patients in each group with normal results in the worth-4 dot test.
Time frame
2 weeks, 4 weeks, 9 weeks, 13 weeks2
Normal proportion in the Bagolini striated glasses test
The proportion of patients in each group with normal results in the Bagolini striated glasses test.
Time frame
2 weeks, 4 weeks, 9 weeks, 13 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Eye & ENT Hospital of Fudan University
Lead sponsor
First Affiliated Hospital of Fujian Medical University
Collaborator
Shanghai Tong Ren Hospital
Collaborator
Jiangsu Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov