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

Sponsor

University of Oklahoma (Other)

Overall Status

Completed

CT.gov ID

NCT05615805

Collaborator

(none)

142

Enrollment

Location

Arms

Actual Duration (Months)

20.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intravitreal Injection Ocular Rinse Age-Related Macular Degeneration Diabetic Macular Edema Cystoid Macular Edema	Other: OSDI questionnaire Other: SPEEDII questionnaire	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

142 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Jul 30, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Ocular Surface Disease Index [24-72 hours after injection]
Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.

Secondary Outcome Measures

Standardized Patient Evaluation of Eye Dryness II [24-72 hours after injection]
Patient symptoms questionnaire, range 0-48, higher score is associated with worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dean McGee Eye Institute	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

University of Oklahoma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oklahoma

ClinicalTrials.gov Identifier:

NCT05615805

Other Study ID Numbers:

IRB #9810

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 14, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Degeneration

Macular Edema

Edema

Study Results

No Results Posted as of Nov 14, 2022