Health TrialsbyHealthPanel

Augmented Reality Training for Amblyopia After Congenital Cataract Surgery

ConditionsDeprivation AmblyopiaCongenital Cataract
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

This study will evaluate whether augmented reality training is effective and safe for treating unilateral amblyopia after congenital cataract surgery in children.

Children aged 5 to 12 years with unilateral amblyopia after congenital cataract surgery will be enrolled from three eye hospitals in China. Participants will be randomly assigned to one of two groups. One group will receive augmented reality amblyopia training for 2 hours per day for 4 months. The other group will receive conventional patching of the fellow eye for 4 hours per day for 4 months.

The main outcome is the change in best-corrected visual acuity of the amblyopic eye after 4 months of treatment. The study will also evaluate contrast sensitivity, binocular visual function, stereoacuity, vision-related symptoms, quality of life, and adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 5 to 12 years, male or female.

Diagnosed with unilateral amblyopia after congenital cataract surgery.

Best-corrected visual acuity (BCVA) of the amblyopic eye ≤0.80 logMAR, BCVA of the fellow eye better than 0.15 logMAR, and interocular BCVA difference ≥0.20 logMAR.

Underwent cataract extraction at age ≤5 years and has stable ocular status at least 2 months after intraocular lens implantation.

Disqualifiers

Childhood cataract caused by causes other than congenital cataract, including traumatic, drug-induced, steroid-related, secondary, or metabolic cataract.

Other ocular organic diseases that may affect visual acuity assessment or amblyopia treatment evaluation, including but not limited to significant ptosis, corneal or other media opacity, glaucoma or persistent ocular hypertension, optic nerve disease, retinal disease, or cortical visual impairment.

Uncontrolled or clinically unstable severe systemic disease that may affect study safety, adherence, or outcome assessment, including active malignancy, severe cardiovascular disease, uncontrolled hypertension, epilepsy, or history of photosensitive epilepsy.

Implanted electronic medical devices that may be affected by the study device or may affect safe use of the device, such as a pacemaker or implantable cardioverter-defibrillator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Augmented Reality Amblyopia Training

    Device

    Participants assigned to the experimental group will receive augmented reality amblyopia training for 2 hours per day for 4 months. Training may be completed in divided sessions, with each session lasting at least 30 minutes when possible. The training system will present visual training tasks and record training duration, task completion, and adherence data.

  • Conventional Patching

    Behavioral

    Participants assigned to the control group will receive conventional patching of the fellow eye for 4 hours per day for 4 months. Participants or their guardians will record daily patching duration and completion in a treatment diary, and adherence will be reviewed during follow-up visits.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Augmented Reality Amblyopia TrainingExperimental treatment 1 intervention
Group B: Conventional PatchingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 4 Months

Best-corrected visual acuity of the amblyopic eye will be measured using the ETDRS visual acuity chart and recorded in logMAR units. The primary outcome is defined as the change from baseline to 4 months, calculated as baseline logMAR BCVA minus 4-month logMAR BCVA. A larger positive value indicates greater visual acuity improvement.

Time frame
Baseline, 4 months

Secondary outcomes

1

Change From Baseline in Contrast Sensitivity at 1 Month and 4 Months

Contrast sensitivity will be measured using the CSV-1000 test at different spatial frequencies, including 3, 6, 12, and 18 cycles per degree. Changes from baseline to 1 month and 4 months will be evaluated.

Time frame
Baseline, 4 months
2

Change From Baseline in Suppression Status at 1 Month and 4 Months

Suppression status will be assessed using the Bagolini striated glasses test and the Worth 4-dot test. The presence or absence of suppression and abnormal retinal correspondence will be recorded and compared across study visits.

Time frame
Baseline, 4 months
3

Change From Baseline in Stereoacuity at 1 Month and 4 Months

Stereoacuity will be assessed using the Randot stereotest for distance and near stereoacuity and the Titmus stereotest for near stereoacuity. Improvement will be defined as an improvement of at least one stereoacuity level from baseline or a change from no measurable stereoacuity to measurable stereoacuity.

Time frame
Baseline, 4 months
4

Change From Baseline in Quality of Life at 1 Month and 4 Months

Quality of life will be assessed using the Chinese version of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales. The scale includes physical, emotional, social, and school functioning domains. Changes from baseline to 1 month and 4 months will be evaluated.

Time frame
Baseline, 4 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongshan Ophthalmic Center, Sun Yat-sen University

Lead sponsor

Shenzhen Eye Hospital

Collaborator

Zhengzhou Second Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: