Clinical trial NCT04074954: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cataract
Diabetes
Hypertension
Obesity
Vision Disability
Lead sponsor: University of Pikeville
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Amount of activity conducted by the patient before receiving surgery
timeFrame: 10 days prior to surgery
measure: Amount of activity conducted by the patient after receiving surgery
timeFrame: 10 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Bennett and Bloom Eye Centers
state: Kentucky
Study officials:
affiliation: University of Pikeville
name: Kelley E Sedlock, OD
role: PRINCIPAL_INVESTIGATOR
References: