NCT05615805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

October 26, 2022

Last Update Submit

April 21, 2023

Conditions

Intravitreal InjectionOcular RinseAge-Related Macular DegenerationDiabetic Macular EdemaCystoid Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Ocular Surface Disease Index

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

    24-72 hours after injection

Secondary Outcomes (1)

  • Standardized Patient Evaluation of Eye Dryness II

    24-72 hours after injection

Study Arms (3)

3-mL washout with saline based ocular rinse post injection

EXPERIMENTAL
Other: OSDI questionnaireOther: SPEEDII questionnaire

10-mL washout with saline based ocular rinse post injection

EXPERIMENTAL
Other: OSDI questionnaireOther: SPEEDII questionnaire

15-mL washout with saline based ocular rinse post injection

EXPERIMENTAL
Other: OSDI questionnaireOther: SPEEDII questionnaire

Interventions

OSDI questionnaireOTHER

Ocular Surface Disease Index

10-mL washout with saline based ocular rinse post injection15-mL washout with saline based ocular rinse post injection3-mL washout with saline based ocular rinse post injection
SPEEDII questionnaireOTHER

Standardized Patient Evaluation of Eye Dryness II questionnaire

10-mL washout with saline based ocular rinse post injection15-mL washout with saline based ocular rinse post injection3-mL washout with saline based ocular rinse post injection

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • choroidal neovascular membrane or cystoid macular edema requiring intravitreal injections for treatment.

You may not qualify if:

  • active ocular infection, eyelid trauma, graft versus host disease, thyroid eye disease, pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Macular DegenerationMacular Edema

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 14, 2022

Study Start

March 1, 2021

Primary Completion

July 30, 2021

Study Completion

October 1, 2021

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

US(1)