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

Primary Purpose

Intravitreal Injection, Ocular Rinse, Age-Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OSDI questionnaire
SPEEDII questionnaire
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intravitreal Injection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dean McGee Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

3-mL washout with saline based ocular rinse post injection

10-mL washout with saline based ocular rinse post injection

15-mL washout with saline based ocular rinse post injection

Arm Description

Outcomes

Primary Outcome Measures

Ocular Surface Disease Index
Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.

Secondary Outcome Measures

Standardized Patient Evaluation of Eye Dryness II
Patient symptoms questionnaire, range 0-48, higher score is associated with worse outcome.

Full Information

First Posted
October 26, 2022
Last Updated
April 21, 2023
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05615805
Brief Title
The Effect of Ocular Rinse Volume on Surface Irritation After Intravitreal Injections
Official Title
The Effect of Ocular Rinse Volume on Surface Irritation After Povidone-iodine Preparation for Intravitreal Injections: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravitreal Injection, Ocular Rinse, Age-Related Macular Degeneration, Diabetic Macular Edema, Cystoid Macular Edema

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3-mL washout with saline based ocular rinse post injection
Arm Type
Experimental
Arm Title
10-mL washout with saline based ocular rinse post injection
Arm Type
Experimental
Arm Title
15-mL washout with saline based ocular rinse post injection
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
OSDI questionnaire
Intervention Description
Ocular Surface Disease Index
Intervention Type
Other
Intervention Name(s)
SPEEDII questionnaire
Intervention Description
Standardized Patient Evaluation of Eye Dryness II questionnaire
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index
Description
Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.
Time Frame
24-72 hours after injection
Secondary Outcome Measure Information:
Title
Standardized Patient Evaluation of Eye Dryness II
Description
Patient symptoms questionnaire, range 0-48, higher score is associated with worse outcome.
Time Frame
24-72 hours after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depending on their required use of the data

Learn more about this trial

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

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