Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses
Purpose To evaluate the efficacy of a new visual training program for improving the visual function in patients implanted with trifocal intraocular lenses (IOLs). Methods Randomised placebo-controlled clinical trial enrolling 60 subjects (age, 47–75 years) undergoing cataract surgery with implantati...
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| Veröffentlicht in: | International ophthalmology 2023-11, Vol.43 (11), p.4035-4053 |
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| creator | Piñero, David P. Maldonado-López, Miguel J. Molina-Martin, Ainhoa García-Sánchez, Noelia Ramón, María L. Rincón, José L. Holgueras, Alfredo Arenillas, Juan F. Planchuelo-Gómez, Álvaro Leal-Vega, Luis Coco-Martín, María Begoña |
| description | Purpose
To evaluate the efficacy of a new visual training program for improving the visual function in patients implanted with trifocal intraocular lenses (IOLs).
Methods
Randomised placebo-controlled clinical trial enrolling 60 subjects (age, 47–75 years) undergoing cataract surgery with implantation of trifocal diffractive IOL. Home-based active visual training was prescribed immediately after surgery to all of them (20 sessions, 30 min): 31 subjects using a serious game based on Gabor patches (study group) and 29 using a placebo software (placebo group). Visual acuity, contrast sensitivity (CS), and perception of visual disturbances (QoV questionnaire) were evaluated before and after training. Likewise, in a small subgroup, resting-state functional magnetic resonance imaging (rs-fMRI) analysis was performed.
Results
No significant differences were found between groups in compliance time (
p
= 0.70). After training, only significant improvements in monocular uncorrected intermediate visual acuity were found in the study group (
p
≤ 0.01), although differences between groups did not reach statistical significance (
p
≥ 0.11). Likewise, significantly better binocular far CS values were found in the study group for the spatial frequencies of 6 (
p
= 0.01) and 12 cpd (
p
= 0.03). More visual symptoms of the QoV questionnaire experienced a significant change in the level of bothersomeness in the study group. Rs-fMRI revealed the presence significant changes reflecting higher functional connectivity after the training with the serious game.
Conclusions
A 3-week visual training program based on the use of Gabor patches after bilateral implantation of trifocal diffractive IOLs may be beneficial for optimising the visual function, with neural changes associated suggesting an acceleration of neuroadaptation.
Trial registration
ClinicalTrials.gov, NCT04985097. Registered 02 August 2021,
https://clinicaltrials.gov/(NCT04985097
). |
| doi_str_mv | 10.1007/s10792-023-02809-9 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10520183</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2839741675</sourcerecordid><originalsourceid>FETCH-LOGICAL-c475t-ebc3cd0c0f64356b9a3036bd8ceb02549c2401661ae5e07ae6d762b245b0d6943</originalsourceid><addsrcrecordid>eNp9ks-K1TAUxosozjj6Ai4k4MZNNU3StFmJDP6DAUF0HdL09N4MaVKT9A4-ly_oqfc6ji5ctD3k_PKd85Wvqp429GVDafcqN7RTrKaM49NTVat71XnTdrxmktP7d-qz6lHO15RS1Sn5sDrjnZCCsf68-vHZhDHOLsNIFm8sDLG2MZQUvccj611w1nhSksM3HIxfTXFhR8oeiJsXYwuJEzEkwA05uLwilWBvBuddQTIGsqS4S2YmWAZYUzSjWU4th12sIJS8iXkTCg69cWW_DZziNtnhMiba1ZtEPIQM-XH1YDI-w5PT96L6-u7tl8sP9dWn9x8v31zVVnRtqWGw3I7U0kkK3spBGU65HMYeTVLWCmWZoI2UjYEWaGdAjp1kAxPtQEepBL-oXh91l3WYYbSwbeL1ktxs0ncdjdN_d4Lb61086Ia2jDY9R4UXJ4UUv62Qi8Y_bcGjUYhr1qznqhON7FpEn_-DXsc1BfSHlOxFz9ADUuxI2RRzTjDdbtNQvYVCH0OhMRT6Vyi0wkvP7vq4vfI7BQjwI5CxFXaQ_sz-j-xPE5bIjQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2868482356</pqid></control><display><type>article</type><title>Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses</title><source>SpringerLink Journals - AutoHoldings</source><creator>Piñero, David P. ; Maldonado-López, Miguel J. ; Molina-Martin, Ainhoa ; García-Sánchez, Noelia ; Ramón, María L. ; Rincón, José L. ; Holgueras, Alfredo ; Arenillas, Juan F. ; Planchuelo-Gómez, Álvaro ; Leal-Vega, Luis ; Coco-Martín, María Begoña</creator><creatorcontrib>Piñero, David P. ; Maldonado-López, Miguel J. ; Molina-Martin, Ainhoa ; García-Sánchez, Noelia ; Ramón, María L. ; Rincón, José L. ; Holgueras, Alfredo ; Arenillas, Juan F. ; Planchuelo-Gómez, Álvaro ; Leal-Vega, Luis ; Coco-Martín, María Begoña</creatorcontrib><description>Purpose
To evaluate the efficacy of a new visual training program for improving the visual function in patients implanted with trifocal intraocular lenses (IOLs).
Methods
Randomised placebo-controlled clinical trial enrolling 60 subjects (age, 47–75 years) undergoing cataract surgery with implantation of trifocal diffractive IOL. Home-based active visual training was prescribed immediately after surgery to all of them (20 sessions, 30 min): 31 subjects using a serious game based on Gabor patches (study group) and 29 using a placebo software (placebo group). Visual acuity, contrast sensitivity (CS), and perception of visual disturbances (QoV questionnaire) were evaluated before and after training. Likewise, in a small subgroup, resting-state functional magnetic resonance imaging (rs-fMRI) analysis was performed.
Results
No significant differences were found between groups in compliance time (
p
= 0.70). After training, only significant improvements in monocular uncorrected intermediate visual acuity were found in the study group (
p
≤ 0.01), although differences between groups did not reach statistical significance (
p
≥ 0.11). Likewise, significantly better binocular far CS values were found in the study group for the spatial frequencies of 6 (
p
= 0.01) and 12 cpd (
p
= 0.03). More visual symptoms of the QoV questionnaire experienced a significant change in the level of bothersomeness in the study group. Rs-fMRI revealed the presence significant changes reflecting higher functional connectivity after the training with the serious game.
Conclusions
A 3-week visual training program based on the use of Gabor patches after bilateral implantation of trifocal diffractive IOLs may be beneficial for optimising the visual function, with neural changes associated suggesting an acceleration of neuroadaptation.
Trial registration
ClinicalTrials.gov, NCT04985097. Registered 02 August 2021,
https://clinicaltrials.gov/(NCT04985097
).</description><identifier>ISSN: 1573-2630</identifier><identifier>ISSN: 0165-5701</identifier><identifier>EISSN: 1573-2630</identifier><identifier>DOI: 10.1007/s10792-023-02809-9</identifier><identifier>PMID: 37464228</identifier><language>eng</language><publisher>Dordrecht: Springer Netherlands</publisher><subject>Acuity ; Binocular vision ; Clinical trials ; Functional magnetic resonance imaging ; Implantation ; Intraocular lenses ; Magnetic lenses ; Magnetic resonance imaging ; Medicine ; Medicine & Public Health ; Neural networks ; Ophthalmology ; Original Paper ; Patients ; Placebos ; Questionnaires ; Rehabilitation ; Subgroups ; Surgery ; Training ; Visual acuity ; Visual perception</subject><ispartof>International ophthalmology, 2023-11, Vol.43 (11), p.4035-4053</ispartof><rights>The Author(s) 2023</rights><rights>2023. The Author(s).</rights><rights>The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-ebc3cd0c0f64356b9a3036bd8ceb02549c2401661ae5e07ae6d762b245b0d6943</citedby><cites>FETCH-LOGICAL-c475t-ebc3cd0c0f64356b9a3036bd8ceb02549c2401661ae5e07ae6d762b245b0d6943</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10792-023-02809-9$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10792-023-02809-9$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27923,27924,41487,42556,51318</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37464228$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Piñero, David P.</creatorcontrib><creatorcontrib>Maldonado-López, Miguel J.</creatorcontrib><creatorcontrib>Molina-Martin, Ainhoa</creatorcontrib><creatorcontrib>García-Sánchez, Noelia</creatorcontrib><creatorcontrib>Ramón, María L.</creatorcontrib><creatorcontrib>Rincón, José L.</creatorcontrib><creatorcontrib>Holgueras, Alfredo</creatorcontrib><creatorcontrib>Arenillas, Juan F.</creatorcontrib><creatorcontrib>Planchuelo-Gómez, Álvaro</creatorcontrib><creatorcontrib>Leal-Vega, Luis</creatorcontrib><creatorcontrib>Coco-Martín, María Begoña</creatorcontrib><title>Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses</title><title>International ophthalmology</title><addtitle>Int Ophthalmol</addtitle><addtitle>Int Ophthalmol</addtitle><description>Purpose
To evaluate the efficacy of a new visual training program for improving the visual function in patients implanted with trifocal intraocular lenses (IOLs).
Methods
Randomised placebo-controlled clinical trial enrolling 60 subjects (age, 47–75 years) undergoing cataract surgery with implantation of trifocal diffractive IOL. Home-based active visual training was prescribed immediately after surgery to all of them (20 sessions, 30 min): 31 subjects using a serious game based on Gabor patches (study group) and 29 using a placebo software (placebo group). Visual acuity, contrast sensitivity (CS), and perception of visual disturbances (QoV questionnaire) were evaluated before and after training. Likewise, in a small subgroup, resting-state functional magnetic resonance imaging (rs-fMRI) analysis was performed.
Results
No significant differences were found between groups in compliance time (
p
= 0.70). After training, only significant improvements in monocular uncorrected intermediate visual acuity were found in the study group (
p
≤ 0.01), although differences between groups did not reach statistical significance (
p
≥ 0.11). Likewise, significantly better binocular far CS values were found in the study group for the spatial frequencies of 6 (
p
= 0.01) and 12 cpd (
p
= 0.03). More visual symptoms of the QoV questionnaire experienced a significant change in the level of bothersomeness in the study group. Rs-fMRI revealed the presence significant changes reflecting higher functional connectivity after the training with the serious game.
Conclusions
A 3-week visual training program based on the use of Gabor patches after bilateral implantation of trifocal diffractive IOLs may be beneficial for optimising the visual function, with neural changes associated suggesting an acceleration of neuroadaptation.
Trial registration
ClinicalTrials.gov, NCT04985097. Registered 02 August 2021,
https://clinicaltrials.gov/(NCT04985097
).</description><subject>Acuity</subject><subject>Binocular vision</subject><subject>Clinical trials</subject><subject>Functional magnetic resonance imaging</subject><subject>Implantation</subject><subject>Intraocular lenses</subject><subject>Magnetic lenses</subject><subject>Magnetic resonance imaging</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Neural networks</subject><subject>Ophthalmology</subject><subject>Original Paper</subject><subject>Patients</subject><subject>Placebos</subject><subject>Questionnaires</subject><subject>Rehabilitation</subject><subject>Subgroups</subject><subject>Surgery</subject><subject>Training</subject><subject>Visual acuity</subject><subject>Visual perception</subject><issn>1573-2630</issn><issn>0165-5701</issn><issn>1573-2630</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9ks-K1TAUxosozjj6Ai4k4MZNNU3StFmJDP6DAUF0HdL09N4MaVKT9A4-ly_oqfc6ji5ctD3k_PKd85Wvqp429GVDafcqN7RTrKaM49NTVat71XnTdrxmktP7d-qz6lHO15RS1Sn5sDrjnZCCsf68-vHZhDHOLsNIFm8sDLG2MZQUvccj611w1nhSksM3HIxfTXFhR8oeiJsXYwuJEzEkwA05uLwilWBvBuddQTIGsqS4S2YmWAZYUzSjWU4th12sIJS8iXkTCg69cWW_DZziNtnhMiba1ZtEPIQM-XH1YDI-w5PT96L6-u7tl8sP9dWn9x8v31zVVnRtqWGw3I7U0kkK3spBGU65HMYeTVLWCmWZoI2UjYEWaGdAjp1kAxPtQEepBL-oXh91l3WYYbSwbeL1ktxs0ncdjdN_d4Lb61086Ia2jDY9R4UXJ4UUv62Qi8Y_bcGjUYhr1qznqhON7FpEn_-DXsc1BfSHlOxFz9ADUuxI2RRzTjDdbtNQvYVCH0OhMRT6Vyi0wkvP7vq4vfI7BQjwI5CxFXaQ_sz-j-xPE5bIjQ</recordid><startdate>20231101</startdate><enddate>20231101</enddate><creator>Piñero, David P.</creator><creator>Maldonado-López, Miguel J.</creator><creator>Molina-Martin, Ainhoa</creator><creator>García-Sánchez, Noelia</creator><creator>Ramón, María L.</creator><creator>Rincón, José L.</creator><creator>Holgueras, Alfredo</creator><creator>Arenillas, Juan F.</creator><creator>Planchuelo-Gómez, Álvaro</creator><creator>Leal-Vega, Luis</creator><creator>Coco-Martín, María Begoña</creator><general>Springer Netherlands</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7T7</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20231101</creationdate><title>Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses</title><author>Piñero, David P. ; Maldonado-López, Miguel J. ; Molina-Martin, Ainhoa ; García-Sánchez, Noelia ; Ramón, María L. ; Rincón, José L. ; Holgueras, Alfredo ; Arenillas, Juan F. ; Planchuelo-Gómez, Álvaro ; Leal-Vega, Luis ; Coco-Martín, María Begoña</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c475t-ebc3cd0c0f64356b9a3036bd8ceb02549c2401661ae5e07ae6d762b245b0d6943</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Acuity</topic><topic>Binocular vision</topic><topic>Clinical trials</topic><topic>Functional magnetic resonance imaging</topic><topic>Implantation</topic><topic>Intraocular lenses</topic><topic>Magnetic lenses</topic><topic>Magnetic resonance imaging</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Neural networks</topic><topic>Ophthalmology</topic><topic>Original Paper</topic><topic>Patients</topic><topic>Placebos</topic><topic>Questionnaires</topic><topic>Rehabilitation</topic><topic>Subgroups</topic><topic>Surgery</topic><topic>Training</topic><topic>Visual acuity</topic><topic>Visual perception</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Piñero, David P.</creatorcontrib><creatorcontrib>Maldonado-López, Miguel J.</creatorcontrib><creatorcontrib>Molina-Martin, Ainhoa</creatorcontrib><creatorcontrib>García-Sánchez, Noelia</creatorcontrib><creatorcontrib>Ramón, María L.</creatorcontrib><creatorcontrib>Rincón, José L.</creatorcontrib><creatorcontrib>Holgueras, Alfredo</creatorcontrib><creatorcontrib>Arenillas, Juan F.</creatorcontrib><creatorcontrib>Planchuelo-Gómez, Álvaro</creatorcontrib><creatorcontrib>Leal-Vega, Luis</creatorcontrib><creatorcontrib>Coco-Martín, María Begoña</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>International ophthalmology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Piñero, David P.</au><au>Maldonado-López, Miguel J.</au><au>Molina-Martin, Ainhoa</au><au>García-Sánchez, Noelia</au><au>Ramón, María L.</au><au>Rincón, José L.</au><au>Holgueras, Alfredo</au><au>Arenillas, Juan F.</au><au>Planchuelo-Gómez, Álvaro</au><au>Leal-Vega, Luis</au><au>Coco-Martín, María Begoña</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses</atitle><jtitle>International ophthalmology</jtitle><stitle>Int Ophthalmol</stitle><addtitle>Int Ophthalmol</addtitle><date>2023-11-01</date><risdate>2023</risdate><volume>43</volume><issue>11</issue><spage>4035</spage><epage>4053</epage><pages>4035-4053</pages><issn>1573-2630</issn><issn>0165-5701</issn><eissn>1573-2630</eissn><abstract>Purpose
To evaluate the efficacy of a new visual training program for improving the visual function in patients implanted with trifocal intraocular lenses (IOLs).
Methods
Randomised placebo-controlled clinical trial enrolling 60 subjects (age, 47–75 years) undergoing cataract surgery with implantation of trifocal diffractive IOL. Home-based active visual training was prescribed immediately after surgery to all of them (20 sessions, 30 min): 31 subjects using a serious game based on Gabor patches (study group) and 29 using a placebo software (placebo group). Visual acuity, contrast sensitivity (CS), and perception of visual disturbances (QoV questionnaire) were evaluated before and after training. Likewise, in a small subgroup, resting-state functional magnetic resonance imaging (rs-fMRI) analysis was performed.
Results
No significant differences were found between groups in compliance time (
p
= 0.70). After training, only significant improvements in monocular uncorrected intermediate visual acuity were found in the study group (
p
≤ 0.01), although differences between groups did not reach statistical significance (
p
≥ 0.11). Likewise, significantly better binocular far CS values were found in the study group for the spatial frequencies of 6 (
p
= 0.01) and 12 cpd (
p
= 0.03). More visual symptoms of the QoV questionnaire experienced a significant change in the level of bothersomeness in the study group. Rs-fMRI revealed the presence significant changes reflecting higher functional connectivity after the training with the serious game.
Conclusions
A 3-week visual training program based on the use of Gabor patches after bilateral implantation of trifocal diffractive IOLs may be beneficial for optimising the visual function, with neural changes associated suggesting an acceleration of neuroadaptation.
Trial registration
ClinicalTrials.gov, NCT04985097. Registered 02 August 2021,
https://clinicaltrials.gov/(NCT04985097
).</abstract><cop>Dordrecht</cop><pub>Springer Netherlands</pub><pmid>37464228</pmid><doi>10.1007/s10792-023-02809-9</doi><tpages>19</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | International ophthalmology, 2023-11, Vol.43 (11), p.4035-4053 |
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| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10520183 |
| source | SpringerLink Journals - AutoHoldings |
| subjects | Acuity Binocular vision Clinical trials Functional magnetic resonance imaging Implantation Intraocular lenses Magnetic lenses Magnetic resonance imaging Medicine Medicine & Public Health Neural networks Ophthalmology Original Paper Patients Placebos Questionnaires Rehabilitation Subgroups Surgery Training Visual acuity Visual perception |
| title | Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses |
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