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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

Brief Summary:
To evaluate the effect of bilateral cataract surgery with intraocular lens implantation on the daily activity levels of elderly patients.

Condition or disease Intervention/treatment
Cataract Diabetes Hypertension Obesity Vision Disability Procedure: Cataract surgery

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: A (Prospective/Pilot) Study Evaluating the Effect of Cataract Surgery on the Daily Activity Levels of Elderly Patients
Estimated Study Start Date : August 26, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
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
Procedure: Cataract surgery
Patients will receive cataract surgery




Primary Outcome Measures :
  1. Amount of activity conducted by the patient before receiving surgery [ Time Frame: 10 days prior to surgery ]
    Measured by a wrist activity tracker

  2. Amount of activity conducted by the patient after receiving surgery [ Time Frame: 10 days after surgery ]
    Measured by a wrist activity tracker



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

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): NCT04074954


Contacts
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Contact: Kelley E Sedlock, OD 8143814042 kelleysedlock@gmail.com
Contact: Ian McWherter, OD 7242444644 ianmcwherter@upike.edu

Locations
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United States, Kentucky
Bennett and Bloom Eye Centers Recruiting
Louisville, Kentucky, United States, 40223
Contact: Kelley E Sedlock, OD    814-381-4042    kelleysedlock@gmail.com   
Sponsors and Collaborators
University of Pikeville
Investigators
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Principal Investigator: Kelley E Sedlock, OD University of Pikeville
  Study Documents (Full-Text)

Documents provided by University of Pikeville:
Study Protocol  [PDF] August 19, 2019


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Responsible Party: University of Pikeville
ClinicalTrials.gov Identifier: NCT04074954     History of Changes
Other Study ID Numbers: CataractStudy1
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vision Disorders
Cataract
Lens Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms