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OpenTrials
Completed

NCT Number: NCT03002688

OSUWMC EEI Sequential Cataract Patient Experience Project

The purpose is to gauge the patients' level of comfort and anxiety for sequential cataract surgeries to assess if the second experience of cataract surgery differs from the initial experience.

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Key information

Conditions

Cataract Surgery Experience

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

Each patient is scheduled to undergo two sequential cataract extractions under topical anesthesia with local anesthetic eye drops and minimal sedation- one on each eye. The surgeon, basic surgical procedure, anesthetic technique, and approximate length of procedure are reasonably similar and the patients act as their own control. Subjects in the study will answer very brief questions regarding anxiety and comfort about their surgery before and after each procedure, and on the day after their second surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing sequential cataract surgeries within a 6 week time period performed by the ophthalmologist, Amit Tandon, MD.
  • Aged 18 years and older.

Exclusion criteria

  • Cognitive impairment causing inability to participate in survey
  • Language barrier causing an inability to participate in survey
  • Healthcare POA or guardian leading to an inability to consent to survey
  • Physician autonomy; patients that are inappropriate for the study as deemed by investigator

Treatment and study plan

Survey

Other

Verbal survey will be given before and after the cataract surgery, and on the day following the second cataract surgery.

Primary outcomes

  1. Pain

    Time frame: First and second cataract extraction surgery occuring within 6 weeks

    Pain will be evaluated using verbal survey after each cataract surgery, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in pain between surgeries on the day after the second cataract surgery.

  2. Anxiety

    Time frame: First and second cataract extraction surgery occuring within 6 weeks

    Anxiety will be evaluated using verbal survey before each cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in anxiety between surgeries on the day after the second cataract surgery.

  3. Awareness

    Time frame: First and second cataract extraction surgery occuring within 6 weeks

    Awareness will be evaluated using verbal survey after each cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in awareness between surgeries on the day after the second cataract surgery.

  4. Comfort Level

    Time frame: First and second cataract extraction surgery occuring within 6 weeks

    Comfort level will be evaluated using verbal survey after cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in comfort level between surgeries on the day after the second cataract surgery.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2016
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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