OSUWMC EEI Sequential Cataract Patient Experience Project

Completed

• Conditions: Cataract Surgery Experience
• Interventions: Other: Survey

• Registration Number: NCT03002688
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Study Start: 2017-01
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sequential Cataract Surgery with Survey	Survey	Subjects eligible for the study will fall into the sequential cataract surgery group and be administered brief surveys.

Primary Outcome Measures

Name	Time	Method
Pain	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.
Anxiety	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.
Awareness	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.
Comfort Level	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.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States