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

Sponsor
University of Pikeville (Other)
Overall Status
Unknown status
CT.gov ID
NCT04074954
Collaborator
(none)
30
1
11.2
2.7

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A (Prospective/Pilot) Study Evaluating the Effect of Cataract Surgery on the Daily Activity Levels of Elderly Patients
Anticipated Study Start Date :
Aug 26, 2019
Anticipated Primary Completion Date :
Jul 31, 2020
Anticipated Study Completion Date :
Jul 31, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Amount of activity conducted by the patient before receiving surgery [10 days prior to surgery]

    Measured by a wrist activity tracker

  2. Amount of activity conducted by the patient after receiving surgery [10 days after surgery]

    Measured by a wrist activity tracker

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bennett and Bloom Eye Centers Louisville Kentucky United States 40223

Sponsors and Collaborators

  • University of Pikeville

Investigators

  • Principal Investigator: Kelley E Sedlock, OD, University of Pikeville

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Pikeville
ClinicalTrials.gov Identifier:
NCT04074954
Other Study ID Numbers:
  • CataractStudy1
First Posted:
Aug 30, 2019
Last Update Posted:
Aug 30, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2019