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Final Report Summary - PROVISIONE (Quality of vision and subjective satisfaction in new non-spectacle systems for restoring accommodation in presbyopic people.)

Summary description Project objectives
The project “Quality of vision and subjective satisfaction in new non-spectacle systems for restoring accommodation in presbyopic people”(or ProVisione for short) aimed to study and extend the knowledge of the relationship between new innovative optical systems for ocular prebyopia correction, the visual outcomes and patient satisfaction. Presbyopia, that is the physiological, age-related loss in near visual function associated with the loss in accommodation, is traditionally corrected with spectacles but nowadays there is an increasing demand of presbyopia non-spectacle correction.
The overall aim of the ProVisione was to study and extend the knowledge about two non-spectacle optical systems developed for restoring functioning in presbyopes: the scleral implant surgery and the monovision induced with contact lenses (CL).
More specifically the project has 5 key research objectives (two main and three additional). The first Research Objective (1RO) aimed to evaluate the effectiveness of these two non-spectacle optical systems for restoring functioning in presbyopes. The second Research Objective (2RO) aimed to evaluate the relative efficacy of these two non-spectacle optical system in comparison to other available systems (such as multifocal CL and intraocular lenses). The third Research Objective (3RO) was an additional objective aimed to monitor the outcomes of 1RO and 2RO longitudinally and the fourth additional Research Objective (4RO) aimed to understand which kind of mechanism (optical, physiological, perceptual) works underneath the two non-spectacle optical systems for restoring functioning in presbyopes. Finally the fifth research objective (5RO) was added at the beginning of the research period in order to develop new instruments to get optical, psychophysical and subjective measures in presbyopic people corrected with non-spectacles options.
Another goal of Provisione project was to allow the fellow to become an independent scientist in the field of vision sciences. In order to reach the research objectives, the researcher planned to fill the gaps in skills and knowledge through an intensive training program divided in specific trainings (ST) required for the research and complementary trainings (CT).

Description of the work performed since the beginning of the project
The researcher was based in Aston University where he set up his office and a lab to perform psychophysics measurement in presbyopic subjects (control group for scleral implant surgery, evaluation of methodological issues such as the comparison between different reading test etc).
The project was divided in two different sectors: training and research.
The training sector foresaw a Work Package (WP1) and it was divided in two main sections: specific research training (ST) and complementary training (CT). The Researcher attended 12 different seminars/conferences in ST and 8 seminars/conferences in CT. Moreover he has collaborated with 9 researchers in different areas of ST and 2 researchers and 3 manufacturers in different areas of CT.
The research sector foresaw a work package (WP2) in three different phases (a preparatory phase an experimental phase and final phase) on different areas:
Research objectives on scleral implant surgery were carried out in the Midland Eye Institute (Solihull, UK). A group of 20 patients (range 53-63 years) that received bilateral Scleral Implants were assessed. A control group was assessed in Aston University.
Research objectives on monovision patients were studied thanks to two different collaborations. The relationship between monovision and the eye movements was explored in a group of 15 naïve presbyopes assessed in the Eye Movements Lab (leading by Dr. Maria De Luca) of the Santa Lucia Foundation in Rome, Italy. A research to study the brain evoked response in presbyopes with monovision correction was carried out in the Lab of Psychophysiology at University of Rome “Foro Italico” leading by Prof. Francesco Di Russo.
The research objective (5RO) that was thought to develop new instruments to get optical, psychophysical and subjective measures from presbyopic people was addressed thanks to different collaborations:
-A new procedure to evaluate the centration of multifocal CL through computerized videocheratography was developed with a team formed by the researcher, the scientist in charge, three researchers from Department of Sciences of Roma Tre University, one CLs manufacturer (Safilens, Italia) and one optical instrument company (CSO, Italia). Twenty-two participants were studied to evaluate accuracy and repeatability of the procedure.
-A study to compare accuracy of 2 clinical reading tests (MNRead and Radner) and the effect of linguistic factor potentially affecting the measures with the two tests was carried out with the collaboration of Dr.Andrea Nini, (lecturer at Manchester University). Fourty-four participants were enrolled in the experiment.
-A study to translate and validate the Near Activity Visual Questionnaire (NAVQ) in Italian was performed in different Italian sites: The “Madonna della Fiducia” Private clinic based in Rome, the Istituto Benigno Zaccagnini in Bologna, the Istituto di Ricerca e studi in Ottica e Optometria di Vinci and finally the Zeri’s private practice in Rome. Six researchers/clinicians joined the study (Beltramo I, Boccardo L, Palumbo P, Petitti V, Wolffsohn JS, Naroo SA). Emerging presbyopes, presbyopes corrected with reading spectacles or progressive lenses, presbyopic patients who wear Monovision or Multifocal CL and finally pseudoaphakic patients were studied for a total of 207 participants.

Description of the main results achieved so far,
Several significant results have been achieved during Provisione project:
-An Italian version of Near Activity Visual Questionnaire (NAVQ) was developed. The availability of validated questionnaire to measure subjectively-perceived visual near function will allow clinicians in ophthalmic field (ophthalmologists, optometrists etc) to assess the relative subjective benefits of presbyopia corrections in Italian speaking patients (5RO).
-A new procedure to assess multifocal CL centration by a computerized Videokeratographic system has been developed and it resulted accurate and reliable (inter and intra-observer).
-Several significant and original results have been achieved with the studies in monovision. For the first time new aspects concerning the perceptual and neurophysiological correlates of monovision (S4) have been found out. This findings can offer new contributes to the understanding of the mechanisms underneath the technique (4RO).
-A collection of contrast sensitivity and visual acuities data in 334 healthy subjects from 6 to 88 years have been collected with a LCD system. The collection has offered the possibility to build a wide data set with normative data for classes of different ages. To provide normative data is a significant result of the project because can allow clinicians to detect suspect pathological condition and improve visual primary care assessment.
-Provisione contributed to create a specific interdisciplinary group of European scientist interested in Presbyopia correction (European Research Presbyopic Group, ERPG). The “ERPG initiative” was started and the group contributed to the scientific organization of the first Presbyopia Global Symposium arranged during the 20th Interdisciplinary Congress of IBZaccagnini Institute held in Bologna on 4- 6 February 2017.
-Provisione project’s dissemination activity was intensive. Seventeen conference presentation and 3 conference posters were delivered. In terms of publications, five papers have been published, two have been already submitted, 3 papers are in submission and 5 papers are in preparation.
-In terms of professional achivements the researcher got the Fellowship of European Academy of Optometry and Optics and the application to be registered as Optometrist to General Optical Council (GOC) has been accepted with the request to complete an adaptation period of 5 days of hospital observation in an NHS Optometric/Ophthalmological clinic.

The expected final results and their potential impact and use
There is a huge interest in correction of presbyopia worldwide because it affects everyone reaching the age of around 45 years. More than one billion people in the world were presbyopic in 2005, we have an ageing population and this number may reach 2 billion by 2050. Moreover European countries there is increasing demand of non-spectacle correction of presbyopia.

The research deliverables indicates that scleral implant surgery doesn’t seem a good non-spectacle option to restore effectively accommodation. Monovision appeared to be more effective. Subjective satisfaction of subjects using this kind of technique is good as well as vision functionality. Brain mechanism of adaptation to the condition work when monovision is set up. Therefore monovision is a suitable non spectacle option to correct presbyopic people both with surgery or CL. However further researches are needed to identify the large individual difference in adaptation and how to improve it.
Finally the availability of a validated procedure to assess multifocal CL centration by a computerized Videokeratographic system will impact the assessment of multifocal CL. This represents a further tool to improve quality of correction in presbyopic patients.

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