Patching Versus Dichoptic Stimulation Using Virtual Reality in Anisometropic Amblyopia
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 主要终点
- Visual acuity at 10 weeks
研究概览
简要总结
Recently, there has been an increased interest in evaluating binocular therapies (e.g perceptual learning and dichoptic treatment) for amblyopia. They are designed to improve amblyopia through binocular stimulation by unlocking binocular visual function. The objective of the study is to compare the visual and sensory outcome of 2-hour patching to dichoptic stimulation using virtual reality head mounted display in the management of patients with moderate anisometropic amblyopia. The investigators will include children older than 6 years and adults up to the age of thirty five years with anisometropic amblyopia who either had no prior treatment for amblyopia or had prior treatment for amblyopia using patching therapy but with residual amblyopia defined as >= 0.3 logMAR lines between the best-corrected visual acuity in the sound eye and in the amblyopic eye and with moderate amblyopia in the more anisometropic eye defined as best-corrected visual acuity better than 6/60 but =< 6/18. Patients will be randomized into 2 groups according to age using stratified randomization:
- Group P: (Patching Group): This group will have 2 hours of patching each day for 10 weeks.
- Group D (Dichoptic Group): This group will have 1 hour of dichoptic stimulation using the virtual reality system twice a week for 10 weeks for a total of 20 hours of training.
详细描述
The investigators are planning to conduct a study to compare the visual and sensory outcome of 2-hour patching to dichoptic stimulation using virtual reality head mounted display in the management of patients with moderate anisometropic amblyopia. This is a randomized clinical trial. The investigators will include children older than 6 years and adults up to the age of thirty five years with anisometropic amblyopia who either had no prior treatment for amblyopia or had prior treatment for amblyopia using patching therapy but with residual amblyopia defined as >= 0.3 logMAR lines between the best-corrected visual acuity in the sound eye and in the amblyopic eye and with moderate amblyopia in the more anisometropic eye defined as best-corrected visual acuity better than 6/60 but =< 6/18.n Recruitment will occur from the Ophthalmology Outpatient Clinics in Kasr El-Ainy Hospital.
Eligible patients who agree to participate in the study will undergo a 1-hour trial session of dichoptic stimulation using the same head-mounted virtual reality system that will be used in the study to ensure that the patient can use the system. Only patients who are able to understand and to complete the 1-hour session will be enrolled in the study.
Patients will be randomized into 2 groups according to age using stratified randomization:
- Group P: (Patching Group): This group will have 2 hours of patching each day for 10 weeks.
- Group D (Dichoptic Group): This group will have 1 hour of dichoptic stimulation using the virtual reality system twice a week for 10 weeks for a total of 20 hours of training.
Patients will be further subdivided into 2 subgroups according to whether prior patching therapy has been done and failed, or the patient has never received any form of patching therapy. The difference in the outcomes in both subgroups will be analyzed separately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with anisometropic amblyopia who had proper optical correction using spectacles or contact lenses for the past 6 weeks. Anisometropic amblyopia will be defined as difference > 0.3 logMAR lines in best-corrected visual acuity with difference in the spherical equivalent of both eyes > 1 D, in the absence of other causes for amblyopia such as organic causes, or manifest strabismus < 5 PD by simultaneous prism and cover test. Patients will be included in the study only if they had no treatment for amblyopia for the past month other than spectacles and/or contact lenses.
排除标准
- •Patients with development delay
- •Prior ocular surgery
- •Co-existing ocular disease
- •Patients with allergy to patch material
- •History of problems with prior use of virtual reality systems
研究组 & 干预措施
Dichoptic arm
Dichoptic visual training will be performed with the patient wearing his spectacles using the computer game included in Vivid Vision (Vivid Vision, San Francisco, USA) which will be run in the Oculus Rift OC CV1 virtual reality head mounted display (Oculus VR, Menlo Park, California, USA). Each subject will have 20 treatment sessions, divided into 1 hour-sessions performed twice a week for 10 weeks. Each session will be 60 minutes. Adherence to the treatment regimen will be assessed by the number of hours spent in training at the end of 5th week.
干预措施: Dichoptic treatment using virtual reality (Other)
Patching
Patients in the control group will be instructed to continue wearing spectacles if required. Patients will be prescribed two continuous hours of daily patching with at least one hour of near activities during patching. Adhesive skin patches will be provided by the study. The parent/patient will be instructed to spend at least one of the hours of patching time each day performing eye-hand coordination activities at near. Adherence to the treatment protocol will be assessed by having the parent call / send a message to an investigator at the start and end of the occlusion sessions completed each day, thus making the most as accurate as possible assessment of the patient's adherence to the prescribed treatment
干预措施: Patching (Other)
结局指标
主要结局
Visual acuity at 10 weeks
时间窗: 10 weeks
Change in amblyopic eye VA letter score from baseline to 10 weeks.
次要结局
- Compliance to treatment(10 weeks)
- Changes in near stereopsis(10 weeks)
- Number of patients developing misalignment(10 weeks)
- Changes in visual acuity in the sound eye(10 weeks)
- Regression of amblyopic eye visual acuity(20 weeks)
研究者
Ahmed Awadein
Professor of Ophthalmology
Cairo University