NCT05640895

Brief Summary

The objective of this study is to explore the perception of pain during intravitreal injection related to the distance of the entry site from the limbus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

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

November 14, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2024

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

November 28, 2022

Last Update Submit

January 28, 2025

Conditions

Pain

Keywords

Intravitreal injectionRetinal diseasesAge-related macular degenerationDiabetic retinopathyRetinal vein occlusionLimbusQuadrants (regions) of the eyeInjection sitePseudophakic/aphakic eyesPhakic eyesPars planaCiliary bodyVitrectomyCrystalline lensRetinaBevacizumabRanibizumabAfliberceptDiabetic macular edemaAnti-VEGF (Vascular Endothelial Growth Factor)Vabysmo

Outcome Measures

Primary Outcomes (1)

  • Visual scale analogues for pain

    Self-reported perception of pain according to analogue pain scale. The analog pain scale is a scale of numbers from 0 to 10 representing the degree of patient's perceived pain. A score of 0 indicates no perception of pain; a score of 10 indicates a perception of the worst pain possible. The scale is also illustrated with face emojis corresponding to a written description of pain perception from no perception of pain, represented by a green, fully smiling face to perception of the worst pain possible, represented by a red, crying, fully frowning face.

    Immediately post-injection

Interventions

Intravitreal injection sitePROCEDURE

Intravitreal injections will be made at varying sites; patients will report on pain perception

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be from university eye clinics scheduled to undergo intravitreal injections

You may qualify if:

  • Age 18 -100 years
  • Diagnosis of diabetic macular edema, age related macular degeneration, or retinal vein occlusion
  • Treated with bevacizumab, ranibizumab, aflibercept
  • The need for at least two intravitreal injections
  • Pseudophakia

You may not qualify if:

  • Texas Department of Corrections medical records
  • Under 18 years-of-age
  • First intravitreal injection experience of patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (4)

  • Peyman GA, Lad EM, Moshfeghi DM. Intravitreal injection of therapeutic agents. Retina. 2009 Jul-Aug;29(7):875-912. doi: 10.1097/IAE.0b013e3181a94f01.

    PMID: 19584648RESULT

  • Gambrell J, Schaal S. Topical anesthesia for intravitreal injection. Expert Opin Drug Deliv. 2012 Jul;9(7):731-3. doi: 10.1517/17425247.2012.685156. Epub 2012 Jun 4.

    PMID: 22657949RESULT

  • Tewari A, Shah GK, Dhalla MS, Blinder KJ. Surface anesthesia for office-based retinal procedures. Retina. 2007 Jul-Aug;27(6):804-5. doi: 10.1097/IAE.0b013e31804b4081. No abstract available.

    PMID: 17621193RESULT

  • Karimi S, Mosavi SA, Jadidi K, Nikkhah H, Kheiri B. Which quadrant is less painful for intravitreal injection? A prospective study. Eye (Lond). 2019 Feb;33(2):304-312. doi: 10.1038/s41433-018-0208-y. Epub 2018 Sep 10.

    PMID: 30202072RESULT

MeSH Terms

Conditions

PainRetinal DiseasesMacular DegenerationDiabetic RetinopathyRetinal Vein OcclusionAphakia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEye DiseasesRetinal DegenerationDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisLens Diseases

Study Officials

  • Touka K Banaee, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 7, 2022

Study Start

November 14, 2022

Primary Completion

December 18, 2023

Study Completion

September 9, 2024

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)