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A (Prospective/Pilot) Study Evaluating the Effect of Cataract Surgery on the Daily Activity Levels of Elderly Patients

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ClinicalTrials.gov Identifier: NCT04074954
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pikeville

Tracking Information
First Submitted Date August 22, 2019
First Posted Date August 30, 2019
Last Update Posted Date August 30, 2019
Estimated Study Start Date August 26, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2019)
  • Amount of activity conducted by the patient before receiving surgery [ Time Frame: 10 days prior to surgery ]
    Measured by a wrist activity tracker
  • Amount of activity conducted by the patient after receiving surgery [ Time Frame: 10 days after surgery ]
    Measured by a wrist activity tracker
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A (Prospective/Pilot) Study Evaluating the Effect of Cataract Surgery on the Daily Activity Levels of Elderly Patients
Official Title A (Prospective/Pilot) Study Evaluating the Effect of Cataract Surgery on the Daily Activity Levels of Elderly Patients
Brief Summary To evaluate the effect of bilateral cataract surgery with intraocular lens implantation on the daily activity levels of elderly patients.
Detailed Description Cataract formation is a natural aging process that can be influenced by environmental factors such as exposure to ultra violet light and diet. Additionally, metabolic disorders, such as diabetes can lead to an earlier development of cataracts. As cataracts develop, a patient's vision can be affected. Reduced vision can limit activities of daily living and may even reduce a patient's mobility. When this occurs, cataract surgery should be considered to help restore a patient's vision. With the obesity and diabetic epidemic, proper diet and exercise is a major health initiative to control these diseases. If a patient's mobility is reduced as a result of poor vision - their ability to achieve adequate daily physical activity may also be effected. It is thought that improvement in vision may increase their activity levels and help combat these health issues. This study will investigate the activity level of patients before and after undergoing cataract surgery to determine how improved vision quality from removal of the natural lens inside the eye and replacement with an artificial intraocular lens effects their activity level.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Week
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients undergoing bilateral cataract surgery and adult patients who have cataracts but are not undergoing cataract. Consecutive patients based on the inclusion criteria will be selected for the study.
Condition
  • Cataract
  • Diabetes
  • Hypertension
  • Obesity
  • Vision Disability
Intervention Procedure: Cataract surgery
Patients will receive cataract surgery
Study Groups/Cohorts
  • Cataracts present, no surgery
    Adult patients undergoing bilateral cataract surgery
  • Cataracts present, yes surgery
    adult patients who have cataracts but are not undergoing cataract surgery
    Intervention: Procedure: Cataract surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 27, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients undergoing bilateral cataract extraction by phacoemulisficatin with intraocular lens implantation and a planned bilateral distance vision target or patients with bilateral cataracts who are not having cataract surgery
  • Patients aged 60 years old or older
  • Best corrected visual acuity worse than 20/20 in each eye (meaning 20/25 or worse)
  • Non-comanged patients

Exclusion Criteria:

  • Greater than 0.76 D pre-operative corneal cylinder, if having cataract surgery without a planned astigmatism correction (I.e Limbal relaxing incision or Toric intraocular lens)
  • Planned implantation of a multifocal intraocular lens
  • Visual field defect which may reduce mobility
  • Wheel chair bound patients
  • Reduced vision from an ocular disease other than cataracts
  • Patients with significant dementia who are not able to fully comprehend the informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Kelley E Sedlock, OD 8143814042 kelleysedlock@gmail.com
Contact: Ian McWherter, OD 7242444644 ianmcwherter@upike.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04074954
Other Study ID Numbers CataractStudy1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Pikeville
Study Sponsor University of Pikeville
Collaborators Not Provided
Investigators
Principal Investigator: Kelley E Sedlock, OD University of Pikeville
PRS Account University of Pikeville
Verification Date August 2019