OSUWMC EEI Sequential Cataract Patient Experience Project

NCT03002688 | Completed

• 1 other identifier: 2016H0032
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Surgery Experience

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

Survey OTHER

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

Sequential Cataract Surgery with Survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Deborah Lowery, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Clinical Anesthesiology

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 26, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)