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

NCT ID: NCT05615805

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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Intravitreal Injection Ocular Rinse Age-Related Macular Degeneration Diabetic Macular Edema Cystoid Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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3-mL washout with saline based ocular rinse post injection

Group Type EXPERIMENTAL

OSDI questionnaire

Intervention Type OTHER

Ocular Surface Disease Index

SPEEDII questionnaire

Intervention Type OTHER

Standardized Patient Evaluation of Eye Dryness II questionnaire

10-mL washout with saline based ocular rinse post injection

Group Type EXPERIMENTAL

OSDI questionnaire

Intervention Type OTHER

Ocular Surface Disease Index

SPEEDII questionnaire

Intervention Type OTHER

Standardized Patient Evaluation of Eye Dryness II questionnaire

15-mL washout with saline based ocular rinse post injection

Group Type EXPERIMENTAL

OSDI questionnaire

Intervention Type OTHER

Ocular Surface Disease Index

SPEEDII questionnaire

Intervention Type OTHER

Standardized Patient Evaluation of Eye Dryness II questionnaire

Interventions

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OSDI questionnaire

Ocular Surface Disease Index

Intervention Type OTHER

SPEEDII questionnaire

Standardized Patient Evaluation of Eye Dryness II questionnaire

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dean McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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IRB #9810

Identifier Type: -

Identifier Source: org_study_id

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