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

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

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Obesity; Diabetes; Cataract; Vision Disability
• Intervention / Treatment: 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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40223
      • Bennett and Bloom Eye Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of activity conducted by the patient before receiving surgery	Measured by a wrist activity tracker	10 days prior to surgery
Amount of activity conducted by the patient after receiving surgery	Measured by a wrist activity tracker	10 days after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2023
• Primary Completion (Estimated): July 31, 2023
• Study Completion (Estimated): July 31, 2023

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Lens Diseases; Sensation Disorders; Cataract; Vision Disorders
• Other Study ID Numbers: CataractStudy1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No