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

NCT ID: NCT04074954

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-23

Study Completion Date

2023-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cataract Diabetes Hypertension Obesity Vision Disability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cataracts present, no surgery

Adult patients undergoing bilateral cataract surgery

No interventions assigned to this group

Cataracts present, yes surgery

adult patients who have cataracts but are not undergoing cataract surgery

Cataract surgery

Intervention Type PROCEDURE

Patients will receive cataract surgery

Interventions

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Cataract surgery

Patients will receive cataract surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pikeville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelley E Sedlock, OD

Role: PRINCIPAL_INVESTIGATOR

University of Pikeville

Locations

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Bennett and Bloom Eye Centers

Louisville, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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CataractStudy1

Identifier Type: -

Identifier Source: org_study_id