Visual Rehabilitation Through Acoustic Biofeedback With Retimax Vision Trainer in Patients With Advanced Age-related Macular Degeneration

NCT04084587 | Completed DMC

• 1 other identifier: 968/2018/DISP/AOUMO
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Macular Degeneration Advanced; Macular Degeneration, Senile; Macular Degeneration, Dry; Macular Scar; Macular Degeneration Nonexudative

Keywords

Rehabilitation; Biofeedback; Retimax Vision Trainer; Age-Related Macular Degeneration; Age-Related Maculopathy; Maculopathies, Age-Related; Retinal Degeneration; Evoked Potentials, Visual

Outcome Measures

Primary Outcomes (8)

• Change in Far Visual Acuity pre and post treatment

  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.

  one week before the treatment starts and one week after the treatment stops

• Change in Contrast Sensitivity pre and post treatment

  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.

  one week before the treatment starts and one week after the treatment stops

• Change in Near Visual Acuity pre and post treatment

  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.

  one week before the treatment starts and one week after the treatment stops

• Change in Reading Speed pre and post treatment

  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.

  one week before the treatment starts and one week after the treatment stops

• Change in Score in the Questionnaire "Quality of Life" pre and post treatment

  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.

  one week before the treatment starts and one week after the treatment stops

• Change in Retinal sensitivity to microperimetry pre and post treatment

  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.

  one week before the treatment starts and one week after the treatment stops

• Change in Fixation in the 2 central degrees pre and post treatment

  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.

  one week before the treatment starts and one week after the treatment stops

• Change in Fixation in the 4 central degrees pre and post treatment

  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.

  one week before the treatment starts and one week after the treatment stops

Study Arms (2)

Treated Group

EXPERIMENTAL

Group A: 15 patients rehabilitated with Retimax Vision Trainer, 10 consecutive sessions of 8 minutes each, performed twice a week in the best eye. Exams performed before and after treatment: * BCVA (ETDRS) * Reading speed (MNREAD) * Contrast sensitivity (Pelli-Robson) * Microperimetry and analysis of fixation (OCT-SLO OPTOS) * QoL (VFQ-25)

Device: Retimax Vision Trainer

Control Group

NO INTERVENTION

Group B: 9 patients control group without rehabilitation. Exams performed twice, at the same time interval elapsed for the treated group: * BCVA (ETDRS) * Reading speed (MNREAD) * Contrast sensitivity (Pelli-Robson) * QoL (VFQ-25)

Interventions

Retimax Vision Trainer DEVICE

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. (1,2) 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.

Treated Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Policlinico di Modena

Modena, 41124, Italy

Location

MeSH Terms

Conditions

Macular Degeneration, Age-Related, 2; Geographic Atrophy; Macular Degeneration; Retinal Degeneration

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary

Study Officials

• Gian Maria Cavallini, Associate Professor

  Dipartimento Chirurgico, Medico, Odontoiatrico e di Scienze Morfologiche con interesse Trapiantologico, Oncologico e di Medicina Rigenerativa -UNIMORE- University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of Ophthalmology, Director, School of Specialization in Ophthalmology

Model Details: Group A: 15 patients rehabilitated with Retimax Vision Trainer, 10 consecutive sessions of 8 minutes each, performed twice a week in the best eye. Group B: 9 patients control group without rehabilitation. Given the need for constancy and collaboration on the part of the patient, these are allocated to the group of treaties or to the controls based on the fact that they declare themselves more or less available: patients who have transport problems, who live farther away or who in any case they cannot guarantee their presence twice a week, they are allocated to the control group.

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: March 7, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Locations

IT (1)