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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05615805
Enrollment
142
Registered
2022-11-14
Start date
2021-03-01
Completion date
2021-10-01
Last updated
2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHEROSDI questionnaire

Ocular Surface Disease Index

OTHERSPEEDII questionnaire

Standardized Patient Evaluation of Eye Dryness II questionnaire

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Ocular Surface Disease Index24-72 hours after injectionPatient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.

Secondary

MeasureTime frameDescription
Standardized Patient Evaluation of Eye Dryness II24-72 hours after injectionPatient symptoms questionnaire, range 0-48, higher score is associated with worse outcome.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026