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Trial record 1 of 1 for:    NCT02182921
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Evaluation of Cataract Surgery Outcome

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ClinicalTrials.gov Identifier: NCT02182921
Recruitment Status : Recruiting
First Posted : July 8, 2014
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
xiangjiazhu, Evidence Based Cataract Study Group

Brief Summary:
The purpose of this study is to evaluate the visual outcome of the cataract surgery, including best uncorrected and corrected visual acuity, spherical equivalent, wavefront aberration and other measurements.

Condition or disease
Cataract High Myopia

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Surgical Outcomes of Cataract Surgery
Study Start Date : August 2013
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract




Primary Outcome Measures :
  1. Change from baseline in visual acuity at one month after cataract surgery [ Time Frame: Follow-up until one month after surgery ]
  2. Change from baseline in spherical equivalent at one month after cataract surgery [ Time Frame: Follow-up until one month after surgery ]
  3. Change from baseline in visual acuity at six months after cataract surgery [ Time Frame: Follow-up until six months after surgery ]
  4. Change from baseline in spherical equivalent at six months after cataract surgery [ Time Frame: Follow-up until six months after cataract surgery ]

Secondary Outcome Measures :
  1. Change from baseline in wavefront aberration at one month after cataract surgery [ Time Frame: Follow-up until one month after surgery ]
  2. Change from baseline in contrast sensitivity at one month after cataract surgery [ Time Frame: Follow-up until one month after surgery ]
  3. Change from baseline in intraocular light scattering at one month after cataract surgery [ Time Frame: Follow-up until one month after surgery ]
  4. Change from baseline in wavefront aberration at six months after cataract surgery [ Time Frame: Follow-up until six months after surgery ]
  5. Change from baseline in contrast sensitivity at six months after cataract surgery [ Time Frame: Follow-up until six months after surgery ]
  6. Change from baseline in intraocular light scattering at six months after cataract surgery [ Time Frame: Follow-up until six months after surgery ]

Other Outcome Measures:
  1. The difference between attempted and achieved refractive correction at one month after cataract surgery [ Time Frame: Follow-up until one month after surgery ]
  2. The difference between attempted and achieved refractive correction at six months after cataract surgery [ Time Frame: Follow-up until six months after surgery ]


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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Medical centre: Eye and ENT Hospital of Fudan University
Criteria

Inclusion Criteria:

  • Clinical diagnosis of cataract
  • Must be able to cooperate with the ophthalmic examination

Exclusion Criteria:

  • Clinical diagnosis of mental illness
  • Mentally disabled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182921


Contacts
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Contact: Yi Lu, MD (86)021-64377134 luyieent@163.com

Locations
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China, Shanghai
Eye and ENT Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200031
Contact: Yi Lu, MD    (86)021-64377134    luyieent@163.com   
Sponsors and Collaborators
Evidence Based Cataract Study Group
Investigators
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Study Chair: Yi Lu, MD Eye and ENT Hospital of Fudan University
Study Director: Xiangjia Zhu, MD Eye and ENT Hospital of Fudan University
Study Director: Jin Yang, MD Eye and ENT Hospital of Fudan University
Principal Investigator: Keke Zhang, MD Eye and ENT Hospital of Fudan University
Principal Investigator: Wenwen He, MD Eye and ENT Hospital of Fudan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: xiangjiazhu, MD, Evidence Based Cataract Study Group
ClinicalTrials.gov Identifier: NCT02182921    
Other Study ID Numbers: NSFC/YOUNG-81100653
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases