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.

Study Overview

• Status: Completed
• Conditions: Cataract Surgery Experience
• Intervention / Treatment: 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
• Enrollment (Actual): 286

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	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.	First and second cataract extraction surgery occuring within 6 weeks
Anxiety	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.	First and second cataract extraction surgery occuring within 6 weeks
Awareness	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.	First and second cataract extraction surgery occuring within 6 weeks
Comfort Level	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.	First and second cataract extraction surgery occuring within 6 weeks

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Deborah Lowery, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2016H0032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO