The Effect of Eye Exercises for the Stimulation of Neuroadaptation After Multifocal Intraocular Lens Implantation on Visual Function and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Contrast Sensitivity
研究概览
简要总结
The goal of this clinical trial is to examine the effects of eye exercises on visual function and quality of life in cataract patients undergoing multifocal intraocular lens implantation. The main questions it aims to answer are:
- Does it improve visual functions?
- Does it improve vision-related quality of life?
Participants in the intervention group will perform 8-step eye exercises at least once a day for 12 weeks. The control group will not practice, they will only be evaluated.
详细描述
This is a randomized controlled clinical trial to be performed on individuals implanted with multifocal intraocular lenses. Necessary permissions were obtained from Hasan Kalyoncu University Non-Interventional Research Ethics Committee, Private Batman Dunya and Private Batman MedicalPoint Hospitals for the study. Participants will be selected from patients who are scheduled for multifocal intraocular lens implantation in the ophthalmology units of the relevant hospitals, who agree to volunteer and sign an informed consent form.
The individuals participating in the study will be randomly divided into two groups as the study group and the control group. Participants will be evaluated for a total of 3 times: before the surgery, at the 1st and 3rd months after the surgery. The number of group participants will be determined according to the power analysis of the data obtained in the first evaluation and considering data loss.
DATA TO BE COLLECTED:
- Demographic information (name, surname, contact information, age, weight, height, occupation, education level, CV, family history, medication, etc.),
- Refractive errors (Astigmatism, myopia, etc.),
- Near, medium, far visual acuity (Snellen Chart),
- Contrast sensitivity (Pelli-Robson contrast sensitivity chart),
- Pupillary Diameter,
- Intraocular pressure,
- Reading speed,
- Vision-related quality of life (National Institute of Eye Health Visual Function Scale (NEI-VFQ-25),
- Anxiety level (State and Trait Anxiety Scale),
- Cognitive performance (Standardized Mini Mental Test).
Refraction errors, visual acuity (near, intermediate and far), contrast sensitivity, intraocular pressure and pupil diameter will be evaluated by the ophthalmologist.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who can read,
- •To adapt to the training program,
- •To be involved in working voluntarily,
排除标准
- •Individuals with a history of eye surgery,
- •Being diagnosed with strabismus,
- •Being diagnosed with glaucoma,
- •Having a history of neurological disease that will affect vision and eye muscles,
- •Having retinal and visual pathway damage,
- •Having functional damage that will prevent the practice of exercises.
结局指标
主要结局
Contrast Sensitivity
时间窗: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
The Pelli-Robson contrast sensitivity test is a wall chart measuring 90 X 60 cm. The chart comprises 8 lines of letters with different contrasts. Each line has 6 letters; the first 3 letters (a triplet) on the left have more contrast than the 3 letters on the right. The contrast also decreases downward from line to line. The size of the letters is 4.9 X 4.9 cm. There are different sets of letters on each side of the chart. It recommends a test distance of 1 m. The logarithmic contrast sensitivity value of the last triplet of which at least 2 letters are correctly seen is marked as the result. The luminance of the test should be 85 candelas/m2 (cd/m2 ); the accepted range is 60 to 120 cd/m2.
Visual acuity
时间窗: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
Snellen chart will be used for visual acuity measurement.
Vision-related quality of life
时间窗: 12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.)
The National Institute of Eye Health Visual Function Scale (NEI-VFQ-25) will be used. This scale is used to evaluate visual function loss due to eye diseases and was developed by Mangione et al. in 1988. In order to make this scale, whose original form consists of 51 questions, more useful, a 25-question form was developed. The short form of 25 questions consists of 3 parts. These sections are respectively; general health and vision, difficulties with activities, and the consequences of vision problems.
次要结局
- Refraction errors(12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.))
- Reading speed(12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.))
- İntraocular Pressure(12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.))
- Pupillary diameter(12 Week (3 times in total, before the operation, at the 1st and 3rd months after the operation.))
研究者
Idrıs Dogan
lecturer
Batman University