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Completed

NCT Number: NCT05615805

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

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.

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Key information

Conditions

Intravitreal Injection Age-Related Macular Degeneration CYSTOID MACULAR EDEMA Diabetic Macular Edema Eye Diseases Macular Degeneration Macular Edema Ocular Rinse Retinal Degeneration Retinal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OSDI questionnaire

Other

Ocular Surface Disease Index

SPEEDII questionnaire

Other

Standardized Patient Evaluation of Eye Dryness II questionnaire

Primary outcomes

  1. Ocular Surface Disease Index

    Time frame: 24-72 hours after injection

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 14, 2022
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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