ClinicalTrials.gov
ClinicalTrials.gov Menu

OSUWMC EEI Sequential Cataract Patient Experience Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03002688
Recruitment Status : Completed
First Posted : December 26, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Deborah Lowery, Ohio State University

Brief Summary:
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.

Condition or disease Intervention/treatment
Cataract Surgery Experience Other: Survey

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 286 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: OSUWMC EEI Sequential Cataract Patient Experience Project
Actual Study Start Date : January 2017
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
Sequential Cataract Surgery with Survey
Subjects eligible for the study will fall into the sequential cataract surgery group and be administered brief surveys.
Other: Survey
Verbal survey will be given before and after the cataract surgery, and on the day following the second cataract surgery.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be identified by their status presenting for surgery with one specific surgeon (A.T.) at the Eye and Ear Center at Gowdy Fields. Access will be through the preoperative anesthesia assessment performed by the attending anesthesiologist.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002688


Locations
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Deborah Lowery, MD Ohio State University

Responsible Party: Deborah Lowery, Assistant Professor Clinical Anesthesiology, Ohio State University
ClinicalTrials.gov Identifier: NCT03002688     History of Changes
Other Study ID Numbers: 2016H0032
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases