xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015334</url>
    </required_header>
    <id_info>
      <org_study_id>H022_Protocol_VR Cataract</org_study_id>
      <nct_id>NCT06015334</nct_id>
    </id_info>
    <brief_title>Assessment of Visual Performance With Virtual Reality After Cataract Surgery</brief_title>
    <official_title>Applying Virtual Reality to Compare Visual Performance Following Bilateral Implantation of TECNIS Synergy vs TECNIS Monofocal Intraocular Lens With Monovision in Patients With Cataract: A Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Janssen, LP</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Hong Kong</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The proposed randomized clinical trial aims to compare visual performance, measured using VR&#xD;
        simulations, in cataract patients implanted either with bilateral trifocal IOL or bilateral&#xD;
        monofocal IOL with monovision. The hypothesis is that patients implanted with trifocal IOL&#xD;
        would exhibit superior visual performance, in both daytime and nighttime conditions, compared&#xD;
        to those with a monofocal IOL with monovision.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cataract surgery provides an opportunity to restore the quality of life by improving vision.&#xD;
        While monofocal intraocular lenses (IOLs) implantation with monovision has been a common&#xD;
        approach for cataract surgery, it may result in limited clarity at the intermediate distance&#xD;
        and reduced depth perception. The advent of multifocal IOLs has expanded the possibilities,&#xD;
        potentially offering increased visual performance in different ranges of vision. However, the&#xD;
        benefits of multifocal IOLs in everyday activities are not fully understood due to the lack&#xD;
        of task-based investigations.&#xD;
  &#xD;
        To address this gap, a virtual reality-based approach is proposed to simulate daily&#xD;
        activities and assess visual performance. This innovative method can provide insights into&#xD;
        how multifocal IOLs enhance activities requiring good binocular vision at varying distances,&#xD;
        a capability monofocal IOLs may lack. A randomized clinical trial is suggested to compare the&#xD;
        TECNIS Synergy multi-focal IOL with the TECNIS monofocal IOL in monovision. Unlike its&#xD;
        bifocal predecessors, the TECNIS Synergy IOL is trifocal, providing clear vision at near,&#xD;
        intermediate, and far distances. The hypothesis is that patients implanted with the TECNIS&#xD;
        Synergy IOL will demonstrate superior visual performance in simulated day and night&#xD;
        conditions compared to those implanted with monofocal IOLs and monovision.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Patients will remain unaware of their specific study arm assignments until the completion of the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Overall Virtual reality (VR) performance score</measure>
      <time_frame>Pre-operation, Month3</time_frame>
      <description>VR performance score measured from all VR simulations</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Task-specific VR performance score</measure>
      <time_frame>Pre-operation, Month3</time_frame>
      <description>VR performance score measured from an individual VR simulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binocular reading speed assessment</measure>
      <time_frame>Pre-operation, Month3</time_frame>
      <description>Reading speed assessed by the MNRead acuity chart</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binocular contrast sensitivity</measure>
      <time_frame>Pre-operation, Month3</time_frame>
      <description>Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distance visual acuity</measure>
      <time_frame>Pre-operation, Day1, Week1, Month1, Month3</time_frame>
      <description>Monocular and binocular uncorrected and corrected distance visual acuity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intermediate (66 cm) visual acuity</measure>
      <time_frame>Month3</time_frame>
      <description>Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Near (40 cm) visual acuity</measure>
      <time_frame>Month3</time_frame>
      <description>Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binocular defocus curve</measure>
      <time_frame>Month3</time_frame>
      <description>Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela [cd]/m2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Photic phenomena</measure>
      <time_frame>Pre-operation, Month3</time_frame>
      <description>Evaluation of photic phenomena by the 30-item quality of vision questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life assessment</measure>
      <time_frame>Pre-operation, Month3</time_frame>
      <description>National Eye Institute 25-item Visual Function Questionnaire Rasch score</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">114</enrollment>
    <condition>Cataract</condition>
    <arm_group>
      <arm_group_label>Bilateral implantation of trifocal intraocular lens</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive bilateral implantation of TECNIS Synergy intraocular lens</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bilateral monofocal intraocular lens implantation with monovision</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive bilateral implantation of TECNIS monofocal intraocular lens</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>cataract surgery with implantation of intraocular lens</intervention_name>
      <description>Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.</description>
      <arm_group_label>Bilateral implantation of trifocal intraocular lens</arm_group_label>
      <arm_group_label>Bilateral monofocal intraocular lens implantation with monovision</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Bilateral cataract&#xD;
  &#xD;
            -  Regular corneal astigmatism&#xD;
  &#xD;
            -  Corneal endothelium cell count &gt;2000 cells/mm2&#xD;
  &#xD;
            -  Clear intraocular media other than cataract&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Concomitant ocular diseases&#xD;
  &#xD;
            -  Irregular corneal aberration&#xD;
  &#xD;
            -  Capsular instability&#xD;
  &#xD;
            -  Systemic disease that may affect vision&#xD;
  &#xD;
            -  History of other intraocular surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christopher Leung, MD, MB ChB</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ChristopherAnita Yau</last_name>
      <phone>39102673</phone>
      <email>anitayky@hku.hk</email>
    </overall_contact>
    <link>
      <url>https://www.semanticscholar.org/paper/Probabilistic-Models-for-Some-Intelligence-and-Rasch/d3203958e1b9c007d06340aad11d41f088875f3e#citing-papers</url>
      <description>Probabilistic Models for Some Intelligence and Attainment Tests</description>
    </link>
    <reference>
      <citation>Zhang F, Sugar A, Jacobsen G, Collins M. Visual function and spectacle independence after cataract surgery: bilateral diffractive multifocal intraocular lenses versus monovision pseudophakia. J Cataract Refract Surg. 2011 May;37(5):853-8. doi: 10.1016/j.jcrs.2010.12.041.</citation>
      <PMID>21511153</PMID>
    </reference>
    <reference>
      <citation>Mahrous A, Ciralsky JB, Lai EC. Revisiting monovision for presbyopia. Curr Opin Ophthalmol. 2018 Jul;29(4):313-317. doi: 10.1097/ICU.0000000000000487.</citation>
      <PMID>29708928</PMID>
    </reference>
    <reference>
      <citation>Chen M, Atebara NH, Chen TT. A comparison of a monofocal Acrysoft IOL using the &quot;blended monovision&quot; formula with the multifocal array IOL for glasses independence after cataract surgery. Ann Ophthalmol (Skokie). 2007 Fall;39(3):237-40. doi: 10.1007/s12009-007-0035-4.</citation>
      <PMID>18025632</PMID>
    </reference>
    <reference>
      <citation>Goldberg DG, Goldberg MH, Shah R, Meagher JN, Ailani H. Pseudophakic mini-monovision: high patient satisfaction, reduced spectacle dependence, and low cost. BMC Ophthalmol. 2018 Nov 9;18(1):293. doi: 10.1186/s12886-018-0963-3.</citation>
      <PMID>30413145</PMID>
    </reference>
    <reference>
      <citation>Smith CE, Allison RS, Wilkinson F, Wilcox LM. Monovision: Consequences for depth perception from large disparities. Exp Eye Res. 2019 Jun;183:62-67. doi: 10.1016/j.exer.2018.09.005. Epub 2018 Sep 17.</citation>
      <PMID>30237103</PMID>
    </reference>
    <reference>
      <citation>Lam AKN, To E, Weinreb RN, Yu M, Mak H, Lai G, Chiu V, Wu K, Zhang X, Cheng TPH, Guo PY, Leung CKS. Use of Virtual Reality Simulation to Identify Vision-Related Disability in Patients With Glaucoma. JAMA Ophthalmol. 2020 May 1;138(5):490-498. doi: 10.1001/jamaophthalmol.2020.0392.</citation>
      <PMID>32191274</PMID>
    </reference>
    <reference>
      <citation>Dick HB, Ang RE, Corbett D, Hoffmann P, Tetz M, Villarrubia A, Palomino C, Castillo-Gomez A, Tsai L, Thomas EK, Janakiraman P. Comparison of 3-month visual outcomes of a new multifocal intraocular lens vs a trifocal intraocular lens. J Cataract Refract Surg. 2022 Nov 1;48(11):1270-1276. doi: 10.1097/j.jcrs.0000000000000971. Epub 2022 May 12.</citation>
      <PMID>35545816</PMID>
    </reference>
    <reference>
      <citation>Ferreira TB, Ribeiro FJ, Silva D, Matos AC, Gaspar S, Almeida S. Comparison of refractive and visual outcomes of 3 presbyopia-correcting intraocular lenses. J Cataract Refract Surg. 2022 Mar 1;48(3):280-287. doi: 10.1097/j.jcrs.0000000000000743.</citation>
      <PMID>34321410</PMID>
    </reference>
    <reference>
      <citation>Ramulu PY, Swenor BK, Jefferys JL, Rubin GS. Description and validation of a test to evaluate sustained silent reading. Invest Ophthalmol Vis Sci. 2013 Jan 23;54(1):673-80. doi: 10.1167/iovs.12-10617.</citation>
      <PMID>23258146</PMID>
    </reference>
    <reference>
      <citation>Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD; National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001 Jul;119(7):1050-8. doi: 10.1001/archopht.119.7.1050.</citation>
      <PMID>11448327</PMID>
    </reference>
    <reference>
      <citation>Mangione CM, Lee PP, Pitts J, Gutierrez P, Berry S, Hays RD. Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ). NEI-VFQ Field Test Investigators. Arch Ophthalmol. 1998 Nov;116(11):1496-504. doi: 10.1001/archopht.116.11.1496.</citation>
      <PMID>9823352</PMID>
    </reference>
    <reference>
      <citation>Petrillo J, Cano SJ, McLeod LD, Coon CD. Using classical test theory, item response theory, and Rasch measurement theory to evaluate patient-reported outcome measures: a comparison of worked examples. Value Health. 2015 Jan;18(1):25-34. doi: 10.1016/j.jval.2014.10.005. Erratum In: Value Health. 2015 Jun;18(4):547.</citation>
      <PMID>25595231</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Professor Christopher K.S. Leung</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>cataract</keyword>
    <keyword>virtual reality</keyword>
    <keyword>multifocal intraocular lens</keyword>
    <keyword>trifocal intraocular lens</keyword>
    <keyword>monovision</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cataract</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Our plan is focused on publishing the analyzed results of our research through peer-review, journals and conference papers. We understand the importance of patient privacy and confidentiality. Therefore, we will not share any individual patient data with any third parties.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015334
  org study id: H022_Protocol_VR Cataract
  nct id: NCT06015334
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  The proposed randomized clinical trial aims to compare visual performance, measured using VR
        simulations, in cataract patients implanted either with bilateral trifocal IOL or bilateral
        monofocal IOL with monovision. The hypothesis is that patients implanted with trifocal IOL
        would exhibit superior visual performance, in both daytime and nighttime conditions, compared
        to those with a monofocal IOL with monovision.
  Cataract surgery provides an opportunity to restore the quality of life by improving vision.
        While monofocal intraocular lenses (IOLs) implantation with monovision has been a common
        approach for cataract surgery, it may result in limited clarity at the intermediate distance
        and reduced depth perception. The advent of multifocal IOLs has expanded the possibilities,
        potentially offering increased visual performance in different ranges of vision. However, the
        benefits of multifocal IOLs in everyday activities are not fully understood due to the lack
        of task-based investigations.
  
        To address this gap, a virtual reality-based approach is proposed to simulate daily
        activities and assess visual performance. This innovative method can provide insights into
        how multifocal IOLs enhance activities requiring good binocular vision at varying distances,
        a capability monofocal IOLs may lack. A randomized clinical trial is suggested to compare the
        TECNIS Synergy multi-focal IOL with the TECNIS monofocal IOL in monovision. Unlike its
        bifocal predecessors, the TECNIS Synergy IOL is trifocal, providing clear vision at near,
        intermediate, and far distances. The hypothesis is that patients implanted with the TECNIS
        Synergy IOL will demonstrate superior visual performance in simulated day and night
        conditions compared to those implanted with monofocal IOLs and monovision.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients with cataract will receive implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Patients will remain unaware of their specific study arm assignments until the completion of the study.
  measure: Overall Virtual reality (VR) performance score
  time frame: Pre-operation, Month3
  description: VR performance score measured from all VR simulations
  measure: Task-specific VR performance score
  time frame: Pre-operation, Month3
  description: VR performance score measured from an individual VR simulation
  measure: Binocular reading speed assessment
  time frame: Pre-operation, Month3
  description: Reading speed assessed by the MNRead acuity chart
  measure: Binocular contrast sensitivity
  time frame: Pre-operation, Month3
  description: Contrast sensitivity assessed by Pelli-Robson contrast sensitivity chart
  measure: Distance visual acuity
  time frame: Pre-operation, Day1, Week1, Month1, Month3
  description: Monocular and binocular uncorrected and corrected distance visual acuity
  measure: Intermediate (66 cm) visual acuity
  time frame: Month3
  description: Monocular and binocular uncorrected and distance-corrected intermediate (66 cm) visual acuity
  measure: Near (40 cm) visual acuity
  time frame: Month3
  description: Monocular and binocular uncorrected and distance-corrected near (40 cm) visual acuity
  measure: Binocular defocus curve
  time frame: Month3
  description: Binocular defocus curve (from +1.0D to -4.0D) under photopic conditions (85 candela [cd]/m2)
  measure: Photic phenomena
  time frame: Pre-operation, Month3
  description: Evaluation of photic phenomena by the 30-item quality of vision questionnaire
  measure: Quality of life assessment
  time frame: Pre-operation, Month3
  description: National Eye Institute 25-item Visual Function Questionnaire Rasch score
  arm group label: Bilateral implantation of trifocal intraocular lens
  arm group type: Active Comparator
  description: Patients will receive bilateral implantation of TECNIS Synergy intraocular lens
  arm group label: Bilateral monofocal intraocular lens implantation with monovision
  arm group type: Active Comparator
  description: Patients will receive bilateral implantation of TECNIS monofocal intraocular lens
  intervention type: Procedure
  intervention name: cataract surgery with implantation of intraocular lens
  description: Cataract surgery with implantation of bilateral trifocal IOL (TECNIS Synergy) implantation or bilateral monofocal IOL (Tecnis monofocal) with monovision.
  arm group label: Bilateral implantation of trifocal intraocular lens
  arm group label: Bilateral monofocal intraocular lens implantation with monovision
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christopher Leung, MD, MB ChB
  role: Principal Investigator
  affiliation: The University of Hong Kong
  last name: ChristopherAnita Yau
  phone: 39102673
  email: anitayky@hku.hk
  url: https://www.semanticscholar.org/paper/Probabilistic-Models-for-Some-Intelligence-and-Rasch/d3203958e1b9c007d06340aad11d41f088875f3e#citing-papers
  description: Probabilistic Models for Some Intelligence and Attainment Tests
  citation: Zhang F, Sugar A, Jacobsen G, Collins M. Visual function and spectacle independence after cataract surgery: bilateral diffractive multifocal intraocular lenses versus monovision pseudophakia. J Cataract Refract Surg. 2011 May;37(5):853-8. doi: 10.1016/j.jcrs.2010.12.041.
  PMID: 21511153
  citation: Mahrous A, Ciralsky JB, Lai EC. Revisiting monovision for presbyopia. Curr Opin Ophthalmol. 2018 Jul;29(4):313-317. doi: 10.1097/ICU.0000000000000487.
  PMID: 29708928
  citation: Chen M, Atebara NH, Chen TT. A comparison of a monofocal Acrysoft IOL using the "blended monovision" formula with the multifocal array IOL for glasses independence after cataract surgery. Ann Ophthalmol (Skokie). 2007 Fall;39(3):237-40. doi: 10.1007/s12009-007-0035-4.
  PMID: 18025632
  citation: Goldberg DG, Goldberg MH, Shah R, Meagher JN, Ailani H. Pseudophakic mini-monovision: high patient satisfaction, reduced spectacle dependence, and low cost. BMC Ophthalmol. 2018 Nov 9;18(1):293. doi: 10.1186/s12886-018-0963-3.
  PMID: 30413145
  citation: Smith CE, Allison RS, Wilkinson F, Wilcox LM. Monovision: Consequences for depth perception from large disparities. Exp Eye Res. 2019 Jun;183:62-67. doi: 10.1016/j.exer.2018.09.005. Epub 2018 Sep 17.
  PMID: 30237103
  citation: Lam AKN, To E, Weinreb RN, Yu M, Mak H, Lai G, Chiu V, Wu K, Zhang X, Cheng TPH, Guo PY, Leung CKS. Use of Virtual Reality Simulation to Identify Vision-Related Disability in Patients With Glaucoma. JAMA Ophthalmol. 2020 May 1;138(5):490-498. doi: 10.1001/jamaophthalmol.2020.0392.
  PMID: 32191274
  citation: Dick HB, Ang RE, Corbett D, Hoffmann P, Tetz M, Villarrubia A, Palomino C, Castillo-Gomez A, Tsai L, Thomas EK, Janakiraman P. Comparison of 3-month visual outcomes of a new multifocal intraocular lens vs a trifocal intraocular lens. J Cataract Refract Surg. 2022 Nov 1;48(11):1270-1276. doi: 10.1097/j.jcrs.0000000000000971. Epub 2022 May 12.
  PMID: 35545816
  citation: Ferreira TB, Ribeiro FJ, Silva D, Matos AC, Gaspar S, Almeida S. Comparison of refractive and visual outcomes of 3 presbyopia-correcting intraocular lenses. J Cataract Refract Surg. 2022 Mar 1;48(3):280-287. doi: 10.1097/j.jcrs.0000000000000743.
  PMID: 34321410
  citation: Ramulu PY, Swenor BK, Jefferys JL, Rubin GS. Description and validation of a test to evaluate sustained silent reading. Invest Ophthalmol Vis Sci. 2013 Jan 23;54(1):673-80. doi: 10.1167/iovs.12-10617.
  PMID: 23258146
  citation: Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD; National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001 Jul;119(7):1050-8. doi: 10.1001/archopht.119.7.1050.
  PMID: 11448327
  citation: Mangione CM, Lee PP, Pitts J, Gutierrez P, Berry S, Hays RD. Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ). NEI-VFQ Field Test Investigators. Arch Ophthalmol. 1998 Nov;116(11):1496-504. doi: 10.1001/archopht.116.11.1496.
  PMID: 9823352
  citation: Petrillo J, Cano SJ, McLeod LD, Coon CD. Using classical test theory, item response theory, and Rasch measurement theory to evaluate patient-reported outcome measures: a comparison of worked examples. Value Health. 2015 Jan;18(1):25-34. doi: 10.1016/j.jval.2014.10.005. Erratum In: Value Health. 2015 Jun;18(4):547.
  PMID: 25595231
  responsible party type: Principal Investigator
  investigator affiliation: The University of Hong Kong
  investigator full name: Professor Christopher K.S. Leung
  investigator title: Clinical Professor
  mesh term: Cataract
  sharing ipd: No
  ipd description: Our plan is focused on publishing the analyzed results of our research through peer-review, journals and conference papers. We understand the importance of patient privacy and confidentiality. Therefore, we will not share any individual patient data with any third parties.