CataractNCT04074954
A (Prospective/Pilot) Study Evaluating the Effect of Cataract Surgery on the Daily Activity Levels of Elderly Patients
An observational study of Cataract and Diabetes, run by University of Pikeville at 1 site in United States.
Trial summary
To evaluate the effect of bilateral cataract surgery with intraocular lens implantation on the daily activity levels of elderly patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cataract, Diabetes, Hypertension
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to 31 Jul 2023
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bennett and Bloom Eye Centers
Louisville, Kentucky, 40223
About this study
To evaluate the effect of bilateral cataract surgery with intraocular lens implantation on the daily activity levels of elderly patients.
Read the 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.
- Conditions
- Cataract, Diabetes, Hypertension, Obesity, Vision Disability
- Being tested
- Cataract surgery
- Medical subject headings
- Cataract, Diabetes Mellitus, Hypertension, Obesity, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
Patients will receive cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of activity conducted by the patient before receiving surgery
Measured by a wrist activity tracker
Measured: 10 days prior to surgery
Amount of activity conducted by the patient after receiving surgery
Measured by a wrist activity tracker
Measured: 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start23 Mar 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Pikeville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelley E Sedlock, OD, Principal investigator, University of Pikeville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074954
- Sponsor's protocol ID
- CataractStudy1
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2019
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A (Prospective/Pilot) Study Evaluating the Effect of Cataract Surgery on the Daily Activity Levels of Elderly Patients
- ClinicalTrials.gov ID
- NCT04074954
- Acronym / sponsor ID
- CataractStudy1
- Conditions
- Cataract, Diabetes, Hypertension, Obesity, Vision Disability
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PikevilleUniversity, hospital or other
- Study start
- 23 Mar 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cataracts present, no surgery | – | –Adult patients undergoing bilateral cataract surgery |
| Cataracts present, yes surgery | – | Procedure: Cataract surgeryadult patients who have cataracts but are not undergoing cataract surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgeryPatients will receive cataract surgery | Procedure or surgery | Cataracts present, yes surgery |
Primary outcome
Amount of activity conducted by the patient before receiving surgery
Time frame: 10 days prior to surgery
Measured by a wrist activity tracker
Amount of activity conducted by the patient after receiving surgery
Time frame: 10 days after surgery
Measured by a wrist activity tracker
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelley E Sedlock, OD principal investigator
University of Pikeville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Diabetes, run by University of Pikeville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of activity conducted by the patient before receiving surgery (time frame: 10 days prior to surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.