The Effect of Ocular Rinse Volume on Surface Irritation After Intravitreal Injections

April 21, 2023 updated by: University of Oklahoma

The Effect of Ocular Rinse Volume on Surface Irritation After Povidone-iodine Preparation for Intravitreal Injections: A Randomized Controlled Trial

This is the first randomized controlled trial looking into post-injection rinse volume of standard ophthalmic eyewash and its affect on patient comfort up to 72 hours after injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose To evaluate whether the volume of wash out rinse after povidone iodine (PI) application for intravitreal injections (IVI) affects patients' ocular surface irritation.

Methods This was a prospective, single-masked, randomized-controlled trial consisting of 142 subjects . A total of 51, 45, and 46 patients received 3-mL, 10-mL, and 15-mL of ocular rinse respectively. Reductions in the Ocular Surface Disease Index (OSDI) and the Standardized Patient Evaluation of Eye Dryness II (SPEED II) surveys, conducted before and at 24-72 hours post-injection, were analyzed.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean McGee Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

choroidal neovascular membrane or cystoid macular edema requiring intravitreal injections for treatment.

Exclusion Criteria:

active ocular infection, eyelid trauma, graft versus host disease, thyroid eye disease, pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3-mL washout with saline based ocular rinse post injection
Other: OSDI questionnaire
Ocular Surface Disease Index
Other: SPEEDII questionnaire
Standardized Patient Evaluation of Eye Dryness II questionnaire
Experimental: 10-mL washout with saline based ocular rinse post injection
Other: OSDI questionnaire
Ocular Surface Disease Index
Other: SPEEDII questionnaire
Standardized Patient Evaluation of Eye Dryness II questionnaire
Experimental: 15-mL washout with saline based ocular rinse post injection
Other: OSDI questionnaire
Ocular Surface Disease Index
Other: SPEEDII questionnaire
Standardized Patient Evaluation of Eye Dryness II questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index
Time Frame: 24-72 hours after injection
Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.
24-72 hours after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Patient Evaluation of Eye Dryness II
Time Frame: 24-72 hours after injection
Patient symptoms questionnaire, range 0-48, higher score is associated with worse outcome.
24-72 hours after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #9810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depending on their required use of the data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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