Visual Rehabilitation Through Acoustic Biofeedback With Retimax Vision Trainer in Patients With Advanced Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Far Visual Acuity pre and post treatment
研究概览
简要总结
At present there are no real therapies able to improve visual performance in patients with age-related macular degeneration, atrophic type. The aim of the study is to verify whether with rehabilitation sessions with Retimax Vision Trainer it is possible to teach the maculopathic patient to exploit the extrafoveal areas of the retina, not affected by atrophy, resorting to an eccentric vision that compensates for the foveal one, thus obtaining a improvement of visual outcomes (far and near vision capacity, sensitivity to contrast to reading, reading speed, fixation capacity and overall quality of life of the visually impaired patient suffering from atrophic senile maculopathy (AMD)). To do this, the study design was conceived as a non-randomized prospective comparative and involves the formation of two groups of patients: a group A of 15 patients who will be rehabilitated with Retimax and a group B of 15 patients who will not be rehabilitated, but only re-evaluated at the same distance of time that will elapse for group A. Eligible patients are affected by atrophic AMD with unstable fixation and better vision in the eye between 1/10 and 4/10 in the absence of other serious eye diseases. As there is currently no real therapy capable of improving visual performance, the demonstration of the positive effect of the visual rehabilitation program with Retimax in patients suffering from atrophic macular degeneration may encourage a wider use of this method. The patient could benefit from a non-invasive, repeatable and cost-effective procedure.
详细描述
Study typology:
prospective, non-randomized, monocentric, comparative study. There is no agreement between promoter and clinical center. There is no agreement between promoter and financier: the study has no funding.
Background:
The Retimax Vision Trainer is an innovative method that aims to increase visual function in patients with eye diseases of various origins and nature, allowing the patient to exploit and optimize their residual visual potential. It is aimed at patients with visual impairments of different origins and severity, such as campimetric deficits, low vision of central origin, degenerative retinal diseases, amblyopia.
It consists of a device for recording bioelectrical responses evoked during the perception of structured visual stimuli and the control of the same by the patient through a sound biofeedback mechanism. This results in an increase in visual capacity, exploiting neuronal plasticity through the activation of alternative neuronal circuits. The device has already been used in clinical practice at the AOU Modena for about a year precisely with the indication of rehabilitation in the visually impaired patients: therefore the current indication includes that of the study in question. Subjects with central low vision, such as those with advanced AMD, tend to develop independently an eccentric fixation area (PRL or Preferred Retinal Locus) which is generally found on the horizontal meridian of the fovea, mainly on the interpapillo-macular beam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were included in the study based on the following criteria:
- •Diagnosis of advanced age-related macular degeneration through examination of the fundus oculi and OCT;
- •Best corrected visual acuity (BCVA) for far in the best eye between 1/10 and 4/10;
- •Collaborating patients with a positive attitude towards a rehabilitation treatment with a bi-weekly commitment.
排除标准
- •The exclusion criteria from the study are:
- •Presence of concomitant retinal or optic nerve pathologies;
- •Eye surgery more recent than six months, except for the cataract for which the cut off is fixed at two months;
- •Poor collaboration by the patient.
结局指标
主要结局
Change in Far Visual Acuity pre and post treatment
时间窗: one week before the treatment starts and one week after the treatment stops
Far Visual Acuity was measured for each eye, with the best refractive correction of visus (BCVA) using Logaritmic Visual Acuity Chart ETDRS, R chart, Precision Vision La Salle Illinois, Usa at 8 feet (2.44m) of distance. The number of letters read by the patient was used for statistical analyzes.
Change in Near Visual Acuity pre and post treatment
时间窗: one week before the treatment starts and one week after the treatment stops
Near visual acuity was measured for each eye, with the best refractive correction of vision (BCVA) using 35 ± 5 cm MNREAD Acuity Charts, Precision Vision La Salle Illinois, USA, distributed in the Italian version by Carl Zeiss Jena GmbH, Germany. This test consists of graphs containing 19 sentences. Each sentence is printed in three lines. The sentences are in different print formats ranging from 1.3 to -0.5 logMAR and each of them is 0.1 logMAR units smaller than the previous sentence (about 80% of the size). Patients read the graphic aloud starting from the largest characters to reach the smallest characters and, simultaneously, the time required for reading and the frequency of errors are recorded. Near visual acuity is measured in relation to the smallest character that the patient can read without making significant errors. LogMAR values were used for statistical analyzes.
Change in Contrast Sensitivity pre and post treatment
时间窗: one week before the treatment starts and one week after the treatment stops
The Contrast Sensitivity was measured for each eye, with the best refractive correction of visus (BCVA) using Pelli-Robson Contrast Sensivity Chart, Precision Vision La Salle Illinois, Usa at 1 m distance. LogSC values were used for statistical analyzes.
Change in Score in the Questionnaire "Quality of Life" pre and post treatment
时间窗: one week before the treatment starts and one week after the treatment stops
To assess the impact that low vision maculopathy has on daily life, patients were subjected to a National Eye Institute Visual Functioning Questionnaire -25 (NEI VFQ-25) translated into Italian. It is a test composed of 25 questions divided into 3 areas: general health and vision, difficulties in daily activities, response to visual problems. The test was released to the patient who completed it independently; in cases of marked low vision, it can be administered directly by reading aloud. For each response, a score was assigned based on the National Eye Institute's indication for a total variable from 0 to 100. Major final score indicates a better quality of life for the patient. For the statistical analyzes the values of the final score of the test were used.
Change in Fixation in the 4 central degrees pre and post treatment
时间窗: one week before the treatment starts and one week after the treatment stops
Patients undergo microperimetry to study retinal sensitivity and fixation. The instrument used to perform the microperimetry is the Spectral OCT-SLO combination imaging system, Optos, Dunfermline, Scotland, UK. The Spectral OCT / SLO is an optical acquisition system designed to capture images of the retinal layers (OCT) simultaneously with confocal images of the ocular fondus (SLO). It is mainly used in OCT mode, but has a specific microperimetry program. The instrument is also equipped with built-in lenses used to correct the patient's refraction (from -20.00 to +18.00 D).In our study the sights used are of the Goldmann III type, white in color, with a duration of 200 ms; 28 points were stimulated arranged according to a grid created around the macula with strategy 4.2. An attenuation scale of 20 dB was used with a maximum stimulus intensity of 400asb equal to 0 dB. The fixation target, established at 100 asb, is represented by a circle of the magnitude of a degree.
Change in Fixation in the 2 central degrees pre and post treatment
时间窗: one week before the treatment starts and one week after the treatment stops
Patients undergo microperimetry to study retinal sensitivity and fixation. The instrument used to perform the microperimetry is the Spectral OCT-SLO combination imaging system, Optos, Dunfermline, Scotland, UK. The Spectral OCT / SLO is an optical acquisition system designed to capture images of the retinal layers (OCT) simultaneously with confocal images of the ocular fondus (SLO). It is mainly used in OCT mode, but has a specific microperimetry program. The instrument is also equipped with built-in lenses used to correct the patient's refraction (from -20.00 to +18.00 D). In our study the sights used are of the Goldmann III type, white in color, with a duration of 200 ms; 28 points were stimulated arranged according to a grid created around the macula with strategy 4.2. An attenuation scale of 20 dB was used with a maximum stimulus intensity of 400asb equal to 0 dB. The fixation target, established at 100 asb, is represented by a circle of the magnitude of a degree.
Change in Reading Speed pre and post treatment
时间窗: one week before the treatment starts and one week after the treatment stops
Reading Speed was measured for each eye, with the best refractive correction of vision (BCVA) using 35 ± 5 cm MNREAD Acuity Charts, Precision Vision La Salle Illinois, USA, distributed in the Italian version by Carl Zeiss Jena GmbH, Germany. Each sentence consists of 60 characters, corresponding to 10 words of standard length, considered 6 characters (including the space between one word and another), so that each sentence can be divided into 10 smaller units. Patients read the graphic aloud and, simultaneously, the time required for reading and the frequency of errors are recorded. The maximum reading speed (MRS) was calculated with reference to the time taken by the patient to read the sentence corresponding to his visual acuity for near. Since the number of words in the sentence is fixed, it is possible with a simple proportion to calculate the reading speed expressed in words per minute (WpM). WpM values were used for statistical analyzes.
Change in Retinal sensitivity to microperimetry pre and post treatment
时间窗: one week before the treatment starts and one week after the treatment stops
Patients undergo microperimetry to study retinal sensitivity and fixation. The instrument used to perform the microperimetry is the Spectral OCT-SLO combination imaging system, Optos, Dunfermline, Scotland, UK. The Spectral OCT / SLO is an optical acquisition system designed to capture images of the retinal layers (OCT) simultaneously with confocal images of the ocular fondus (SLO). It is mainly used in OCT mode, but has a specific microperimetry program. The instrument is also equipped with built-in lenses used to correct the patient's refraction (from -20.00 to +18.00 D). In our study the sights used are of the Goldmann III type, white in color, with a duration of 200 ms; 28 points were stimulated arranged according to a grid created around the macula with strategy 4.2. An attenuation scale of 20 dB was used with a maximum stimulus intensity of 400asb equal to 0 dB. The fixation target, established at 100 asb, is represented by a circle of the magnitude of a degree.
次要结局
未报告次要终点
研究者
Gian Maria Cavallini
Associate Professor, Head of Ophthalmology, Director, School of Specialization in Ophthalmology
University of Modena and Reggio Emilia