OSUWMC EEI Sequential Cataract Patient Experience Project

Cataract Surgery Experience Clinical Trial

Official title:

OSUWMC EEI Sequential Cataract Patient Experience Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002688
• Other study ID #: 2016H0032
• Status: Completed
• First received: December 15, 2016
• Last updated: April 10, 2018
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery Experience

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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